Fecal microbiota transplant

{{Short description|Process of transplantation of fecal bacteria from a healthy individual into a recipient}} {{Redirect|Use of human faeces in medicine|its use in traditional medicine|Use of human faeces in traditional medicine}} {{Use mdy dates|date=January 2024}} {{Use American English|date=May 2016}} {{cs1 config |name-list-style=vanc |display-authors=6}} {{Infobox medical intervention (new) | name = Fecal microbiota transplant | synonyms = Fecal bacteriotherapy, fecal transfusion, fecal transplant, stool transplant | image = E coli at 10000x, original.jpg | caption = ''Escherichia coli'' at 10,000× magnification | alt = | pronounce = | specialty = Gastroenterology | uses = | complications = | approach = | types = | recovery time = | other options = | outcomes = | frequency = | cost = }}

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| legal_AU = | legal_AU_comment = C2<ref name="Faecal microbiota">{{cite web | title=FAECAL MICROBIOTA TRANSPLANT (FMT) (BiomeBank) | website=Therapeutic Goods Administration (TGA) | date=2024-05-02 | url=https://www.tga.gov.au/resources/prescription-medicines-registrations/faecal-microbiota-transplant-fmt-biomebank | access-date=2024-07-04 | archive-date=January 2, 2024 | archive-url=https://web.archive.org/web/20240102051607/https://www.tga.gov.au/resources/prescription-medicines-registrations/faecal-microbiota-transplant-fmt-biomebank | url-status=live }}</ref> | legal_BR =  | legal_BR_comment = | legal_CA =  | legal_CA_comment = | legal_DE =  | legal_DE_comment = | legal_NZ =  | legal_NZ_comment = | legal_UK =  | legal_UK_comment = | legal_US =  | legal_US_comment = | legal_EU = | legal_EU_comment = | legal_UN =  | legal_UN_comment = | legal_status =

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'''Fecal microbiota transplant''' ('''FMT'''), also known as a '''stool transplant''',<ref>{{cite news |vauthors=Rowan K |url=https://news.yahoo.com/poop-transplants-may-combat-bacterial-infections-130609662.html |title='Poop Transplants' May Combat Bacterial Infections |date=October 20, 2012 |access-date=October 20, 2012 |work=LiveScience |archive-date=November 11, 2020 |archive-url=https://web.archive.org/web/20201111192152/http://news.yahoo.com/poop-transplants-may-combat-bacterial-infections-130609662.html |url-status=live }}</ref> is the process of transferring fecal bacteria and other microbes from a healthy individual into an unhealthy individual. FMT is an effective treatment for ''Clostridioides difficile'' infection (CDI).<ref name="vanNood2013"/><ref>{{cite journal | vauthors = Moayyedi P, Yuan Y, Baharith H, Ford AC | title = Faecal microbiota transplantation for <em>Clostridium difficile</em>-associated diarrhoea: a systematic review of randomised controlled trials | journal = The Medical Journal of Australia | volume = 207 | issue = 4 | pages = 166–172 | date = August 2017 | pmid = 28814204 | doi = 10.5694/mja17.00295 | s2cid = 24780848 }}</ref><ref name=":0">{{cite journal | vauthors = Baunwall SM, Andreasen SE, Hansen MM, Kelsen J, Høyer KL, Rågård N, Eriksen LL, Støy S, Rubak T, Damsgaard EM, Mikkelsen S, Erikstrup C, Dahlerup JF, Hvas CL | title = Faecal microbiota transplantation for first or second Clostridioides difficile infection (EarlyFMT): a randomised, double-blind, placebo-controlled trial | journal = The Lancet. Gastroenterology & Hepatology | volume = 7 | issue = 12 | pages = 1083–1091 | date = December 2022 | pmid = 36152636 | doi = 10.1016/S2468-1253(22)00276-X | s2cid = 252483680 }}</ref> For recurrent CDI, FMT is more effective than vancomycin alone, and may improve the outcome after the first index infection.<ref name="vanNood2013"/><ref name=":0" /><ref>{{cite journal | vauthors = Baunwall SM, Lee MM, Eriksen MK, Mullish BH, Marchesi JR, Dahlerup JF, Hvas CL | title = Faecal microbiota transplantation for recurrent ''Clostridioides difficile'' infection: An updated systematic review and meta-analysis | journal = eClinicalMedicine | volume = 29-30 | article-number = 100642 | date = December 2020 | pmid = 33437951 | pmc = 7788438 | doi = 10.1016/j.eclinm.2020.100642 | doi-access = free }}</ref>

Side effects include a risk of infections; therefore, donors should be screened for pathogens.<ref>{{cite web |url=https://www.fda.gov/safety/medical-product-safety-information/fecal-microbiota-transplantation-safety-alert-risk-serious-adverse-events-likely-due-transmission |title=Fecal Microbiota for Transplantation: Safety Alert - Risk of Serious Adverse Events Likely Due to Transmission of Pathogenic Organisms |date=March 12, 2020 |website=U.S. Food and Drug Administration (FDA) |access-date=March 21, 2020 |archive-date=October 21, 2020 |archive-url=https://web.archive.org/web/20201021174505/https://www.fda.gov/safety/medical-product-safety-information/fecal-microbiota-transplantation-safety-alert-risk-serious-adverse-events-likely-due-transmission }}</ref>

With CDI becoming more common, FMT is gaining prominence. Some experts call for it to become the first-line therapy for CDI.<ref name="Brandt"/> FMT has been used experimentally to treat other gastrointestinal diseases, including colitis, constipation, irritable bowel syndrome, and neurological conditions, such as multiple sclerosis and Parkinson's.<ref name="BorodyKhoruts2011"/><ref>{{cite journal | vauthors = Borody TJ, Paramsothy S, Agrawal G | title = Fecal microbiota transplantation: indications, methods, evidence, and future directions | journal = Current Gastroenterology Reports | volume = 15 | issue = 8 | article-number = 337 | date = August 2013 | pmid = 23852569 | pmc = 3742951 | doi = 10.1007/s11894-013-0337-1 }}</ref> In the United States, human feces have been regulated as an experimental drug since 2013. In the United Kingdom, FMT regulation is under the remit of the Medicines and Healthcare products Regulatory Agency.<ref name="auto">{{cite journal | vauthors = Mullish BH, Quraishi MN, Segal JP, McCune VL, Baxter M, Marsden GL, Moore DJ, Colville A, Bhala N, Iqbal TH, Settle C, Kontkowski G, Hart AL, Hawkey PM, Goldenberg SD, Williams HR | title = The use of faecal microbiota transplant as treatment for recurrent or refractory ''Clostridium difficile'' infection and other potential indications: joint British Society of Gastroenterology (BSG) and Healthcare Infection Society (HIS) guidelines | journal = Gut | volume = 67 | issue = 11 | pages = 1920–1941 | date = November 2018 | pmid = 30154172 | doi = 10.1136/gutjnl-2018-316818 | hdl-access = free | doi-access = free | hdl = 10044/1/61310 }}</ref>

== Medical uses == === ''Clostridioides difficile'' infection === {{further|Michael Seth Silverman| Clostridioides difficile infection}} thumb|Scanning electron micrograph of ''Clostridioides difficile'' bacteria from a stool sample

Fecal microbiota transplant is approximately 85–90% effective in people with CDI for whom antibiotics have not worked or in whom the disease recurs following antibiotics.<ref name=Burke2013>{{cite journal | vauthors = Burke KE, Lamont JT | title = Fecal transplantation for recurrent Clostridium difficile infection in older adults: a review | journal = Journal of the American Geriatrics Society | volume = 61 | issue = 8 | pages = 1394–1398 | date = August 2013 | pmid = 23869970 | doi = 10.1111/jgs.12378 | s2cid = 34998497 | doi-access = free }}</ref><ref name="Drekonja_2015">{{cite journal | vauthors = Drekonja D, Reich J, Gezahegn S, Greer N, Shaukat A, MacDonald R, Rutks I, Wilt TJ | title = Fecal Microbiota Transplantation for Clostridium difficile Infection: A Systematic Review | journal = Annals of Internal Medicine | volume = 162 | issue = 9 | pages = 630–638 | date = May 2015 | pmid = 25938992 | doi = 10.7326/m14-2693 | s2cid = 1307726 }}</ref> Most patients recover with a single FMT treatment.<ref name="Brandt">{{cite journal | vauthors = Brandt LJ, Borody TJ, Campbell J | title = Endoscopic fecal microbiota transplantation: "first-line" treatment for severe clostridium difficile infection? | journal = Journal of Clinical Gastroenterology | volume = 45 | issue = 8 | pages = 655–657 | date = September 2011 | pmid = 21716124 | doi = 10.1097/MCG.0b013e3182257d4f | s2cid = 2508836 | doi-access = free }}</ref><ref name="Bakken"/><ref>{{cite journal | vauthors = Kelly CR, de Leon L, Jasutkar N | title = Fecal microbiota transplantation for relapsing Clostridium difficile infection in 26 patients: methodology and results | journal = Journal of Clinical Gastroenterology | volume = 46 | issue = 2 | pages = 145–149 | date = February 2012 | pmid = 22157239 | doi = 10.1097/MCG.0b013e318234570b | s2cid = 30849491 }}</ref>

A 2009 study found that FMT was an effective and simple procedure that was more cost-effective than continued antibiotic administration and reduced the incidence of antibiotic resistance.<ref>{{cite journal | vauthors = Bakken JS | title = Fecal bacteriotherapy for recurrent Clostridium difficile infection | journal = Anaerobe | volume = 15 | issue = 6 | pages = 285–289 | date = December 2009 | pmid = 19778623 | doi = 10.1016/j.anaerobe.2009.09.007 }}</ref>

Once considered to be a "last-resort therapy" by some medical professionals, due to its unusual nature and invasiveness compared with antibiotics, perceived potential risk of infection transmission, and lack of Medicare coverage for donor stool, position statements by specialists in infectious diseases and other societies<ref name="Bakken"/> have moved toward acceptance as a standard therapy for relapsing CDI and toward US Medicare.<ref>{{cite journal | vauthors = Floch MH | title = Fecal bacteriotherapy, fecal transplant, and the microbiome | journal = Journal of Clinical Gastroenterology | volume = 44 | issue = 8 | pages = 529–530 | date = September 2010 | pmid = 20601895 | doi = 10.1097/MCG.0b013e3181e1d6e2 | s2cid = 32439751 | doi-access = free }}</ref>

It has been recommended that endoscopic FMT be elevated to first-line treatment for people with deterioration and severe relapsing ''C. difficile'' infection.<ref name="Brandt"/>

In November 2022, FMT (Biomictra) was approved for medical use in Australia,<ref name="Faecal microbiota" /><ref name="BiomeBank PR" /> and fecal microbiota, live (Rebyota) was approved for medical use in the United States.<ref name="Ferring PR">{{cite press release | title=Ferring Receives U.S. FDA Approval for Rebyota (fecal microbiota, live-jslm) – A Novel First-in-Class Microbiota-Based Live Biotherapeutic | website=Ferring Pharmaceuticals USA | date=December 1, 2022 | url=https://ferringusa.com/?press=ferring-receives-u-s-fda-approval-for-rebyota-fecal-microbiota-live-jslm-a-novel-first-in-class-microbiota-based-live-biotherapeutic | access-date=December 1, 2022 | archive-date=December 1, 2022 | archive-url=https://web.archive.org/web/20221201050237/https://ferringusa.com/?press=ferring-receives-u-s-fda-approval-for-rebyota-fecal-microbiota-live-jslm-a-novel-first-in-class-microbiota-based-live-biotherapeutic | url-status=live }}</ref>

Fecal microbiota spores, live (Vowst) was approved for medical use in the United States in April 2023.<ref name="FDA PR 20230427">{{cite press release | title=FDA Approves First Orally Administered Fecal Microbiota Product for the Prevention of Recurrence of Clostridioides difficile Infection | website=U.S. Food and Drug Administration (FDA) | date=April 26, 2023 | url=https://www.fda.gov/news-events/press-announcements/fda-approves-first-orally-administered-fecal-microbiota-product-prevention-recurrence-clostridioides | access-date=April 27, 2023 | archive-date=April 26, 2023 | archive-url=https://web.archive.org/web/20230426230158/https://www.fda.gov/news-events/press-announcements/fda-approves-first-orally-administered-fecal-microbiota-product-prevention-recurrence-clostridioides }}</ref><ref>{{cite press release | title=Seres Therapeutics and Nestlé Health Science Announce FDA Approval of Vowst (fecal microbiota spores, live-brpk) for Prevention of Recurrence of C. difficile Infection in Adults Following Antibacterial Treatment for Recurrent CDI | publisher=Seres Therapeutics | via= Business Wire | date=April 26, 2023 | url=https://www.businesswire.com/news/home/20230426006066/en/ | access-date=April 27, 2023}}</ref> It is the first fecal microbiota product that is taken by mouth.<ref name="FDA PR 20230427" />

== FMT Used in Cancer Test Trials (2026) == In 2026, two trials were announced in Ontario, Canada, one in January and another in May. One was used to test the efficacy of FMT in cancer immunotherapy. In a report, Dr. Michael Silverman, a specialist in infectious diseases at the Lawson Research Institute of St. Joseph's Health Care, has been interviewed on gut microbe and its role in customized FMT treatments for cancer treatment. The Canadian Cancer Society announced the biggest clinical trial in the country, testing the FMT capsules during chemotherapy for lung cancer. The trial is funded by a $4 million dollar backing by the CCS and the Weston Family Foundation.<ref>{{Cite AV media |url=https://www.youtube.com/watch?v=OCljfVU4IRQ |title=Dr Silverman on CBC |date=2026-05-22 |last=Eli Rubenstein |access-date=2026-05-22 |via=YouTube}}</ref><ref name=":1">{{Cite AV media |url=https://www.youtube.com/watch?v=qtUXG7iiXPk |title=Largest-ever Canadian clinical trial tests "poop pills" to improve immunotherapy for lung cancer |date=2026-05-20 |last=LHSCCanada |access-date=2026-05-22 |via=YouTube}}</ref><ref name=":2">{{Cite AV media |url=https://www.youtube.com/watch?v=BW9nE1I9l1s |title=Clinical trial to use ‘poop pills’ to improve immunotherapy in lung cancer patients |date=2026-05-20 |last=CTV News |access-date=2026-05-22 |via=YouTube}}</ref>

Dr. Silverman explained that FMTs should be understood as more than simply “poop pills.” In his view, the treatment involves introducing a carefully selected, healthy community of microorganisms from young, healthy donors in order to help stimulate the immune system so it can better recognize and work against cancer, while maintaining safety. He also noted that London has developed exceptional expertise in this area, with more experience using FMTs in cancer patients than any other centre in the world.<ref name=":2" /><ref name=":1" />

==== Ulcerative colitis ==== In May 1988, Australian professor Thomas Borody treated the first ulcerative colitis patient using FMT, which led to longstanding symptom resolution.<ref name="ReferenceA">{{cite journal | vauthors = Borody TJ, Campbell J | title = Fecal microbiota transplantation: current status and future directions | journal = Expert Review of Gastroenterology & Hepatology | volume = 5 | issue = 6 | pages = 653–655 | date = December 2011 | pmid = 22017691 | doi = 10.1586/egh.11.71 | s2cid = 8968197 }}</ref> Following on from that, Justin D. Bennet published the first case report documenting reversal of Bennet's own colitis using FMT.<ref>{{cite journal | vauthors = Bennet JD, Brinkman M | title = Treatment of ulcerative colitis by implantation of normal colonic flora | journal = Lancet | volume = 1 | issue = 8630 | page = 164 | date = January 1989 | pmid = 2563083 | doi = 10.1016/S0140-6736(89)91183-5 | s2cid = 33842920 }}</ref> While ''C. difficile'' is easily eradicated with a single FMT infusion, this generally appears to not be the case with ulcerative colitis. Published experience of ulcerative colitis treatment with FMT largely shows that multiple and recurrent infusions are required to achieve prolonged remission or cure.<ref name="ReferenceA"/><ref>{{cite journal | vauthors = Sunkara T, Rawla P, Ofosu A, Gaduputi V | title = Fecal microbiota transplant - a new frontier in inflammatory bowel disease | journal = Journal of Inflammation Research | volume = 11 | pages = 321–328 | date = 2018 | pmid = 30214266 | pmc = 6124474 | doi = 10.2147/JIR.S176190 | doi-access = free }}</ref>

==== Cancer ==== Clinical trials are underway {{As of|2020|lc=y}} to evaluate if FMT from anti-PD-1 immunotherapy donors can promote a therapeutic response in immunotherapy-refractory patients.<ref>{{cite journal | vauthors = Davar D, Dzutsev AK, McCulloch JA, Rodrigues RR, Chauvin JM, Morrison RM, Deblasio RN, Menna C, Ding Q, Pagliano O, Zidi B, Zhang S, Badger JH, Vetizou M, Cole AM, Fernandes MR, Prescott S, Costa RG, Balaji AK, Morgun A, Vujkovic-Cvijin I, Wang H, Borhani AA, Schwartz MB, Dubner HM, Ernst SJ, Rose A, Najjar YG, Belkaid Y, Kirkwood JM, Trinchieri G, Zarour HM | title = Fecal microbiota transplant overcomes resistance to anti-PD-1 therapy in melanoma patients | journal = Science | volume = 371 | issue = 6529 | pages = 595–602 | date = February 2021 | pmid = 33542131 | pmc = 8097968 | doi = 10.1126/science.abf3363 | s2cid = 231808119 | bibcode = 2021Sci...371..595D }}</ref><ref>{{cite journal | vauthors = Baruch EN, Youngster I, Ben-Betzalel G, Ortenberg R, Lahat A, Katz L, Adler K, Dick-Necula D, Raskin S, Bloch N, Rotin D, Anafi L, Avivi C, Melnichenko J, Steinberg-Silman Y, Mamtani R, Harati H, Asher N, Shapira-Frommer R, Brosh-Nissimov T, Eshet Y, Ben-Simon S, Ziv O, Khan MA, Amit M, Ajami NJ, Barshack I, Schachter J, Wargo JA, Koren O, Markel G, Boursi B | title = Fecal microbiota transplant promotes response in immunotherapy-refractory melanoma patients | journal = Science | volume = 371 | issue = 6529 | pages = 602–609 | date = February 2021 | pmid = 33303685 | doi = 10.1126/science.abb5920 | s2cid = 228101416 | doi-access = free | bibcode = 2021Sci...371..602B }}</ref>

==== Autism ==== Once linked with naturopathy,<ref>{{cite news | vauthors = Lindsay B |date=January 10, 2020 |title=B.C. naturopath's pricey fecal transplants for autism are experimental and risky, scientists say |url=https://www.cbc.ca/news/canada/british-columbia/bc-naturopath-fecal-transplants-autism-1.5420048 |work=CBC News |location=British Columbia |access-date=August 31, 2023}}</ref> there have been serious studies into treating autism with fecal microbiota transplants. One such study was conducted in Shanghai, China,<ref>{{cite journal | vauthors = Li Y, Wang Y, Zhang T | title = Fecal Microbiota Transplantation in Autism Spectrum Disorder | journal = Neuropsychiatric Disease and Treatment | volume = 18 | pages = 2905–2915 | date = December 15, 2022 | pmid = 36544550 | pmc = 9762410 | doi = 10.2147/NDT.S382571 | doi-access = free }}</ref> and an earlier study led by Arizona State University.<ref>{{cite journal | vauthors = Kang DW, Adams JB, Gregory AC, Borody T, Chittick L, Fasano A, Khoruts A, Geis E, Maldonado J, McDonough-Means S, Pollard EL, Roux S, Sadowsky MJ, Lipson KS, Sullivan MB, Caporaso JG, Krajmalnik-Brown R | title = Microbiota Transfer Therapy alters gut ecosystem and improves gastrointestinal and autism symptoms: an open-label study | journal = Microbiome | volume = 5 | issue = 1 | article-number = 10 | date = January 2017 | pmid = 28122648 | pmc = 5264285 | doi = 10.1186/s40168-016-0225-7 | doi-access = free | author-link4 = Thomas Borody }}</ref> The Arizona treatment has received a United States Patent (#11,202,808),<ref>{{cite news|vauthors=Leander S|url=https://news.asu.edu/20220201-treatment-autism-symptoms-earns-asu-researchers-patent|title=Treatment for autism symptoms earns ASU researchers patent: Microbiota Transplant Therapy offering hope to those with autism spectrum disorder|work=ASU News|date=February 1, 2022|access-date=August 31, 2023|archive-date=August 31, 2023|archive-url=https://web.archive.org/web/20230831193957/https://news.asu.edu/20220201-treatment-autism-symptoms-earns-asu-researchers-patent|url-status=live}}</ref> though the researchers stress the need for further research due to the small sample size and open-label nature of their research.<ref>{{cite news|vauthors=Innes S|url=https://www.azcentral.com/story/news/local/arizona-health/2019/04/11/asu-research-autism-symptoms-improved-fecal-transplants-intestinal-health/3424039002/|title=ASU researchers see hope for autism symptoms with fecal transplants|work=The Arizona Republic|date=April 11, 2019|access-date=August 31, 2023|archive-date=August 31, 2023|archive-url=https://web.archive.org/web/20230831212718/https://www.azcentral.com/story/news/local/arizona-health/2019/04/11/asu-research-autism-symptoms-improved-fecal-transplants-intestinal-health/3424039002/|url-status=live}}</ref>

====Fibromyalgia and IBS==== A 2024 review found that fecal microbiota transplantation may reduce pain intensity and improve fatigue and quality of life in patients with fibromyalgia.<ref>{{Cite web|url=https://www.researchgate.net/publication/386174088|title=Effectiveness of Fecal Microbiota Transplantation in Nociplastic Pain Management: A Systematic Review}}</ref><ref>{{cite journal | vauthors = Fang H, Hou Q, Zhang W, Su Z, Zhang J, Li J, Lin J, Wang Z, Yu X, Yang Y, Wang Q, Li X, Li Y, Hu L, Li S, Wang X, Liao L | title = Fecal Microbiota Transplantation Improves Clinical Symptoms of Fibromyalgia: An Open-Label, Randomized, Nonplacebo-Controlled Study | journal = The Journal of Pain | volume = 25 | issue = 9 | article-number = 104535 | date = September 2024 | pmid = 38663650 | doi = 10.1016/j.jpain.2024.104535 }}</ref><ref>{{cite journal | vauthors = Minerbi A, Khoutorsky A, Shir Y | title = Decoding the connection: unraveling the role of gut microbiome in fibromyalgia | journal = Pain Reports | volume = 10 | issue = 1 | article-number = e1224 | date = February 2025 | pmid = 39726854 | doi = 10.1097/PR9.0000000000001224 | pmc = 11671092 }}</ref> A 2023 review found that fecal microbiota transplantation improved symptoms of irritable bowel syndrome compared to a placebo.<ref name="Jamshidi IBS 2023">{{cite journal | vauthors = Jamshidi P, Farsi Y, Nariman Z, Hatamnejad MR, Mohammadzadeh B, Akbarialiabad H, Nasiri MJ, Sechi LA | title = Fecal Microbiota Transplantation in Irritable Bowel Syndrome: A Systematic Review and Meta-Analysis of Randomized Controlled Trials | journal = International Journal of Molecular Sciences | volume = 24 | issue = 19 | article-number = 14562 | date = September 2023 | pmid = 37834010 | doi = 10.3390/ijms241914562 | doi-access = free | pmc = 10573019 }}</ref>

==== Obesity ==== A 2025 New Zealand study of 87 obese adolescents who were treated with fecal microbiota transplantation found that after four years there was an 11.2kg difference between the placebo group and the treated group. The treated group also had a waist circumference 8cm less than the placebo group and less body fat. Researchers at the Liggins Institute at Auckland University are working to develop a commercially viable treatment.<ref>{{Cite news |date=11 September 2025 |title=NZ faecal transfer study could change obesity treatment |url=https://www.rnz.co.nz/life/wellbeing/nz-faecal-transfer-study-could-change-obesity-treatment |access-date=24 September 2025 |work=Radio NZ}}</ref>

== Adverse effects ==

Adverse effects were poorly understood as of 2016.<ref name=AdverseRev2016/> They have included bacterial blood infections, fever, SIRS-like syndrome, exacerbation of inflammatory bowel disease in people who also had that condition, and mild GI distress which generally resolve themselves soon after the procedure, including flatulence, diarrhea, irregular bowel movements, abdominal distension/bloating, abdominal pain/tenderness, constipation, cramping, and nausea.<ref name=AdverseRev2016>{{cite journal | vauthors = Baxter M, Colville A | title = Adverse events in faecal microbiota transplant: a review of the literature | journal = The Journal of Hospital Infection | volume = 92 | issue = 2 | pages = 117–127 | date = February 2016 | pmid = 26803556 | doi = 10.1016/j.jhin.2015.10.024 | url = https://rde.openrepository.com/rde/handle/11287/595264 | access-date = November 7, 2018 | url-status = live | hdl-access = free | type = Submitted manuscript | archive-date = April 28, 2023 | archive-url = https://web.archive.org/web/20230428050554/https://rde.dspace-express.com/handle/11287/595264 | hdl = 11287/595264 }}</ref><ref>{{cite journal | vauthors = Goloshchapov OV, Olekhnovich EI, Sidorenko SV, Moiseev IS, Kucher MA, Fedorov DE, Pavlenko AV, Manolov AI, Gostev VV, Veselovsky VA, Klimina KM, Kostryukova ES, Bakin EA, Shvetcov AN, Gumbatova ED, Klementeva RV, Shcherbakov AA, Gorchakova MV, Egozcue JJ, Pawlowsky-Glahn V, Suvorova MA, Chukhlovin AB, Govorun VM, Ilina EN, Afanasyev BV | title = Long-term impact of fecal transplantation in healthy volunteers | journal = BMC Microbiology | volume = 19 | issue = 1 | article-number = 312 | date = December 2019 | pmid = 31888470 | pmc = 6938016 | doi = 10.1186/s12866-019-1689-y | doi-access = free }}</ref> There are also concerns that it may spread COVID-19.<ref>{{cite web |author=Office of the Commissioner |title=Fecal Microbiota for Transplantation: Safety Alert - Regarding Additional Safety Protections Pertaining to SARS-CoV-2 and COVID-19 |url=https://www.fda.gov/safety/medical-product-safety-information/fecal-microbiota-transplantation-safety-alert-regarding-additional-safety-protections-pertaining |website=U.S. Food and Drug Administration (FDA) |access-date=March 25, 2020 |date=March 24, 2020 |archive-date=April 14, 2020 |archive-url=https://web.archive.org/web/20200414045959/https://www.fda.gov/safety/medical-product-safety-information/fecal-microbiota-transplantation-safety-alert-regarding-additional-safety-protections-pertaining }}</ref>

In 2019, a person died in the United States after receiving an FMT that contained drug-resistant bacteria, and another person who received the same transplant was also infected.<ref name=FDA2019/><ref>{{cite news|url=https://www.nytimes.com/2019/06/13/health/fecal-transplant-fda.html|title=Fecal Transplant Is Linked to a Patient's Death, the F.D.A. Warns|vauthors=Grady D|date=June 13, 2019|newspaper=The New York Times|access-date=June 14, 2019|archive-date=June 14, 2019|archive-url=https://web.archive.org/web/20190614064558/https://www.nytimes.com/2019/06/13/health/fecal-transplant-fda.html|url-status=live}}</ref> The US Food and Drug Administration (FDA) issued a warning against potentially life-threatening consequences of transplanting material from improperly screened donors.<ref name=FDA2019>{{cite web |title=Fecal Microbiota for Transplantation: Safety Communication- Risk of Serious Adverse Reactions Due to Transmission of Multi-Drug Resistant Organisms |url=https://www.fda.gov/safety/medwatch-safety-alerts-human-medical-products/fecal-microbiota-transplantation-safety-communication-risk-serious-adverse-reactions-due |website=U.S. Food and Drug Administration (FDA) |access-date=June 18, 2019 |date=June 14, 2019 |archive-date=September 4, 2019 |archive-url=https://web.archive.org/web/20190904210827/https://www.fda.gov/safety/medwatch-safety-alerts-human-medical-products/fecal-microbiota-transplantation-safety-communication-risk-serious-adverse-reactions-due }}</ref>

== Technique == There are evidence-based consensus guidelines for the optimal administration of FMT. Such documents outline the FMT procedure, including preparation of material, donor selection and screening, and FMT administration.<ref name="auto" /><ref name="Bakken"/><ref name="Cammarota2017" /><ref>{{cite journal | vauthors = Mullish BH, Quraishi MN, Segal JP, McCune VL, Baxter M, Marsden GL, Moore D, Colville A, Bhala N, Iqbal TH, Settle C, Kontkowski G, Hart AL, Hawkey PM, Williams HR, Goldenberg SD | title = The use of faecal microbiota transplant as treatment for recurrent or refractory Clostridium difficile infection and other potential indications: joint British Society of Gastroenterology (BSG) and Healthcare Infection Society (HIS) guidelines | journal = The Journal of Hospital Infection | volume = 100 | issue = Suppl 1 | pages = S1–S31 | date = September 2018 | pmid = 30173851 | doi = 10.1016/j.jhin.2018.07.037 | hdl-access = free | doi-access = free | hdl = 10044/1/61310 }}</ref>

The gut microbiota comprises all microorganisms that reside along the gastrointestinal tract, including commensal, symbiotic and pathogenic organisms. FMT is the transfer of fecal material containing bacteria and natural antibacterials from a healthy individual into a diseased recipient.<ref name="Bakken">{{cite journal | vauthors = Bakken JS, Borody T, Brandt LJ, Brill JV, Demarco DC, Franzos MA, Kelly C, Khoruts A, Louie T, Martinelli LP, Moore TA, Russell G, Surawicz C | title = Treating Clostridium difficile infection with fecal microbiota transplantation | journal = Clinical Gastroenterology and Hepatology | volume = 9 | issue = 12 | pages = 1044–1049 | date = December 2011 | pmid = 21871249 | pmc = 3223289 | doi = 10.1016/j.cgh.2011.08.014 }}</ref>

=== Donor selection === Preparing for the procedure requires careful selection and screening of the potential donor. Close relatives are often chosen on account of ease of screening;<ref name="Bakken"/><ref name="Cammarota2017">{{cite journal | vauthors = Cammarota G, Ianiro G, Tilg H, Rajilić-Stojanović M, Kump P, Satokari R, Sokol H, Arkkila P, Pintus C, Hart A, Segal J, Aloi M, Masucci L, Molinaro A, Scaldaferri F, Gasbarrini G, Lopez-Sanroman A, Link A, de Groot P, de Vos WM, Högenauer C, Malfertheiner P, Mattila E, Milosavljević T, Nieuwdorp M, Sanguinetti M, Simren M, Gasbarrini A | title = European consensus conference on faecal microbiota transplantation in clinical practice | journal = Gut | volume = 66 | issue = 4 | pages = 569–580 | date = April 2017 | pmid = 28087657 | pmc = 5529972 | doi = 10.1136/gutjnl-2016-313017 }}</ref><ref name="Merenstein2015">{{cite journal | vauthors = Merenstein D, El-Nachef N, Lynch SV | title = Fecal microbial therapy: promises and pitfalls | journal = Journal of Pediatric Gastroenterology and Nutrition | volume = 59 | issue = 2 | pages = 157–161 | date = August 2014 | pmid = 24796803 | pmc = 4669049 | doi = 10.1097/mpg.0000000000000415 }}</ref> however, in the case of treatment of active ''C. diff.'', family members and intimate contacts may be more prone to be carriers themselves.<ref name="Bakken"/> This screening involves medical history questionnaires, screening for various chronic medical diseases (e.g. irritable bowel diseases, Crohn's disease, gastrointestinal cancer, etc.),<ref name="Cammarota2017"/><ref>{{cite journal | vauthors = Woodworth MH, Carpentieri C, Sitchenko KL, Kraft CS | title = Challenges in fecal donor selection and screening for fecal microbiota transplantation: A review | journal = Gut Microbes | volume = 8 | issue = 3 | pages = 225–237 | date = May 2017 | pmid = 28129018 | pmc = 5479407 | doi = 10.1080/19490976.2017.1286006 }}</ref><ref name="Jorgensen2017">{{cite journal | vauthors = Jørgensen SM, Hansen MM, Erikstrup C, Dahlerup JF, Hvas CL | title = Faecal microbiota transplantation: establishment of a clinical application framework | journal = European Journal of Gastroenterology & Hepatology | volume = 29 | issue = 11 | pages = e36–e45 | date = November 2017 | pmid = 28863010 | doi = 10.1097/meg.0000000000000958 | s2cid = 25600294 }}</ref><ref name="Terveer2017">{{cite journal | vauthors = Terveer EM, van Beurden YH, Goorhuis A, Seegers JF, Bauer MP, van Nood E, Dijkgraaf MG, Mulder CJ, Vandenbroucke-Grauls CM, Verspaget HW, Keller JJ, Kuijper EJ | title = How to: Establish and run a stool bank | journal = Clinical Microbiology and Infection | volume = 23 | issue = 12 | pages = 924–930 | date = December 2017 | pmid = 28529025 | doi = 10.1016/j.cmi.2017.05.015 | hdl-access = free | doi-access = free | hdl = 1887/117537 }}</ref> and laboratory testing for pathogenic gastrointestinal infections (e.g. CMV, ''C. diff.'', salmonella, Giardia, GI parasites, etc.).<ref name="Bakken"/><ref name="Cammarota2017"/><ref name="Jorgensen2017"/>

=== Specimen preparation === No laboratory standards have been agreed upon,<ref name="Jorgensen2017"/> so recommendations vary for size of sample to be prepared, ranging from {{convert|30|to|100|g|abbr=off}} of fecal material for effective treatment.<ref name="Drekonja_2015"/><ref name="Cammarota2017"/><ref name="Merenstein2015"/><ref name="Terveer2017"/> Fresh stool is used to increase viability of bacteria within the stool<ref name="Jorgensen2017"/><ref name="Terveer2017"/> and samples are prepared within 6–8 hours.<ref name="Cammarota2017"/><ref name="Jorgensen2017"/><ref name="Terveer2017"/> The sample is then diluted with 2.5–5 times the volume of the sample with either normal saline,<ref name="Cammarota2017"/><ref name="Jorgensen2017"/> sterile water,<ref name="Cammarota2017"/><ref name="Jorgensen2017"/> or 4% milk.<ref name="Bakken"/> Some locations mix the sample and the solvent with a mortar and pestle,<ref name="Terveer2017"/> and others use a blender.<ref name="Cammarota2017"/><ref name="Jorgensen2017"/><ref name="Terveer2017"/> There is concern with blender use on account of the introduction of air which may decrease efficacy<ref name="BorodyKhoruts2011">{{cite journal | vauthors = Borody TJ, Khoruts A | title = Fecal microbiota transplantation and emerging applications | journal = Nature Reviews. Gastroenterology & Hepatology | volume = 9 | issue = 2 | pages = 88–96 | date = December 2011 | pmid = 22183182 | doi = 10.1038/nrgastro.2011.244 | s2cid = 16747221 }}</ref> as well as aerosolization of the feces contaminating the preparation area.<ref name="Cammarota2017"/><ref name="Terveer2017"/> The suspension is then strained through a filter and transferred to an administration container.<ref name="Cammarota2017"/><ref name="Jorgensen2017"/><ref name="Terveer2017"/> If the suspension is to be used later, it can be frozen after being diluted with 10% glycerol,<ref name="Cammarota2017"/><ref name="Jorgensen2017"/><ref name="Terveer2017"/> and used without loss of efficacy compared to the fresh sample.<ref name="Cammarota2017"/><ref name="Merenstein2015"/> The fecal transplant material is then prepared and administered in a clinical environment to ensure that precautions are taken.<ref name="BorodyKhoruts2011"/>

=== Administration === After being made into suspensions, the fecal material can be given through nasogastric and nasoduodenal tubes, or through a colonoscope or as a retention enema.<ref name="Bakken"/>

== Mechanism of action == One hypothesis behind fecal microbiota transplant rests on the concept of bacterial interference, i.e., using harmless bacteria to displace pathogenic organisms, such as by competitive niche exclusion.<ref>{{cite journal | vauthors = Khoruts A, Sadowsky MJ | title = Understanding the mechanisms of faecal microbiota transplantation | journal = Nature Reviews. Gastroenterology & Hepatology | volume = 13 | issue = 9 | pages = 508–516 | date = September 2016 | pmid = 27329806 | pmc = 5909819 | doi = 10.1038/nrgastro.2016.98 }}</ref> In the case of CDI, the ''C. difficile'' pathogen is identifiable.<ref>{{cite journal | vauthors = Kelly CR, Kahn S, Kashyap P, Laine L, Rubin D, Atreja A, Moore T, Wu G | title = Update on Fecal Microbiota Transplantation 2015: Indications, Methodologies, Mechanisms, and Outlook | journal = Gastroenterology | volume = 149 | issue = 1 | pages = 223–237 | date = July 2015 | pmid = 25982290 | pmc = 4755303 | doi = 10.1053/j.gastro.2015.05.008 }}</ref> Recently, in a pilot study of five patients, sterile fecal filtrate was demonstrated to be of comparable efficacy to conventional FMT in the treatment of recurrent CDI.<ref>{{cite journal | vauthors = Ott SJ, Waetzig GH, Rehman A, Moltzau-Anderson J, Bharti R, Grasis JA, Cassidy L, Tholey A, Fickenscher H, Seegert D, Rosenstiel P, Schreiber S | title = Efficacy of Sterile Fecal Filtrate Transfer for Treating Patients With Clostridium difficile Infection | journal = Gastroenterology | volume = 152 | issue = 4 | pages = 799–811.e7 | date = March 2017 | pmid = 27866880 | doi = 10.1053/j.gastro.2016.11.010 | hdl-access = free | doi-access = free | hdl = 21.11116/0000-0002-F84B-3 }}</ref> The conclusion from this study was that soluble filtrate components (such as bacteriophages, metabolites, and/or bacterial components, such as enzymes) may be the key mediators of FMT's efficacy, rather than intact bacteria. It has now been demonstrated that the short-chain fatty acid valerate is restored in human fecal samples from CDI patients and a bioreactor model of recurrent CDI by FMT, but not by antibiotic cessation alone;<ref>{{cite journal | vauthors = McDonald JA, Mullish BH, Pechlivanis A, Liu Z, Brignardello J, Kao D, Holmes E, Li JV, Clarke TB, Thursz MR, Marchesi JR | title = Inhibiting Growth of Clostridioides difficile by Restoring Valerate, Produced by the Intestinal Microbiota | journal = Gastroenterology | volume = 155 | issue = 5 | pages = 1495–1507.e15 | date = November 2018 | pmid = 30025704 | pmc = 6347096 | doi = 10.1053/j.gastro.2018.07.014 }}</ref> as such, this may be a key mediator of FMT's efficacy. Other studies have identified rapid-onset but well-maintained changes in the gut bacteriophage profile after successful FMT (with colonisation of the recipient with donor bacteriophages),<ref>{{cite journal | vauthors = Zuo T, Wong SH, Lam K, Lui R, Cheung K, Tang W, Ching JY, Chan PK, Chan MC, Wu JC, Chan FK, Yu J, Sung JJ, Ng SC | title = Bacteriophage transfer during faecal microbiota transplantation in ''Clostridium difficile'' infection is associated with treatment outcome | journal = Gut | volume = 67 | issue = 4 | pages = 634–643 | date = April 2018 | pmid = 28539351 | pmc = 5868238 | doi = 10.1136/gutjnl-2017-313952 }}</ref><ref>{{cite journal | vauthors = Draper LA, Ryan FJ, Smith MK, Jalanka J, Mattila E, Arkkila PA, Ross RP, Satokari R, Hill C | title = Long-term colonisation with donor bacteriophages following successful faecal microbial transplantation | journal = Microbiome | volume = 6 | issue = 1 | article-number = 220 | date = December 2018 | pmid = 30526683 | pmc = 6288847 | doi = 10.1186/s40168-018-0598-x | doi-access = free }}</ref> and this is therefore another key area of interest.

In contrast, in the case of other conditions such as ulcerative colitis, no single culprit has yet been identified.<ref name="zhang">{{cite journal | vauthors = Zhang YJ, Li S, Gan RY, Zhou T, Xu DP, Li HB | title = Impacts of gut bacteria on human health and diseases | journal = International Journal of Molecular Sciences | volume = 16 | issue = 4 | pages = 7493–7519 | date = April 2015 | pmid = 25849657 | pmc = 4425030 | doi = 10.3390/ijms16047493 | doi-access = free }}</ref> However, analysis of gut microbiome and metabolome changes after FMT as treatment for ulcerative colitis has identified some possible candidates of interest.<ref>{{cite journal | vauthors = Paramsothy S, Nielsen S, Kamm MA, Deshpande NP, Faith JJ, Clemente JC, Paramsothy R, Walsh AJ, van den Bogaerde J, Samuel D, Leong RW, Connor S, Ng W, Lin E, Borody TJ, Wilkins MR, Colombel JF, Mitchell HM, Kaakoush NO | title = Specific Bacteria and Metabolites Associated With Response to Fecal Microbiota Transplantation in Patients With Ulcerative Colitis | journal = Gastroenterology | volume = 156 | issue = 5 | pages = 1440–1454.e2 | date = April 2019 | pmid = 30529583 | doi = 10.1053/j.gastro.2018.12.001 | doi-access = free | hdl = 1959.4/unsworks_64257 | hdl-access = free }}</ref>

== History == The first use of donor feces as a therapeutic agent for food poisoning and diarrhea was recorded in the ''Handbook of Emergency Medicine'' by a Chinese man, Hong Ge, in the 4th century. Twelve hundred years later, Ming dynasty physician Li Shizhen used "yellow soup" (aka "golden syrup") which contained fresh, dry or fermented stool to treat abdominal diseases.<ref name=gerke>{{cite web| vauthors = Gerke H |title=Whats the lowdown on 'fecal transplantation'?|url=http://medcom.uiowa.edu/health/fecal-transplantation/|website=Health at Iowa|publisher=U of Iowa|access-date=January 14, 2015|date=December 2014|archive-date=March 14, 2017|archive-url=https://web.archive.org/web/20170314080738/http://medcom.uiowa.edu/health/fecal-transplantation/}}</ref> "Yellow soup" was made of fecal matter and water, which was drunk by the person.<ref name=JHC13>{{cite web|url=https://www.hopkinsmedicine.org/news/media/releases/therapeutic_poop_hope_for_cure_of_childhood_diarrhea_comes_straight_from_the_gut|title=Therapeutic Poop: Hope for Cure of Childhood Diarrhea Comes Straight from the Gut|work=The Johns Hopkins Children's Center|publisher=The Johns Hopkins University|date=July 29, 2013|access-date=March 31, 2019|archive-date=March 31, 2019|archive-url=https://web.archive.org/web/20190331170602/https://www.hopkinsmedicine.org/news/media/releases/therapeutic_poop_hope_for_cure_of_childhood_diarrhea_comes_straight_from_the_gut|url-status=live}}</ref>

The consumption of "fresh, warm camel feces" has also been recommended by Bedouins as a remedy for bacterial dysentery; its efficacy, probably attributable to the antimicrobial subtilisin produced by ''Bacillus subtilis,'' was anecdotally confirmed by German soldiers of the Afrika Korps during World War II.<ref name=lewin>{{cite journal | vauthors = Lewin RA | title = More on Merde | journal = Perspectives in Biology and Medicine | volume = 44 | issue = 4 | pages = 594–607 | year = 2001 | pmid = 11600805 | doi = 10.1353/pbm.2001.0067 | s2cid = 201764383 }}</ref> However, this story is likely a myth; independent research was not able to verify any of these claims.<ref>{{cite journal | vauthors = Koopman N, van Leeuwen P, Brul S, Seppen J | title = History of fecal transplantation; camel feces contains limited amounts of Bacillus subtilis spores and likely has no traditional role in the treatment of dysentery | journal = PLOS ONE | volume = 17 | issue = 8 | article-number = e0272607 | date = August 10, 2022 | pmid = 35947590 | pmc = 9365175 | doi = 10.1371/journal.pone.0272607 | doi-access = free | bibcode = 2022PLoSO..1772607K }}</ref>

The first use of FMT in western medicine was published in 1958 by Ben Eiseman and colleagues, a team of surgeons from Colorado, who treated four critically ill people with fulminant pseudomembranous colitis (before ''C. difficile'' was the known cause) using fecal enemas, which resulted in a rapid return to health.<ref name="Eiseman">{{cite journal | vauthors = Eiseman B, Silen W, Bascom GS, Kauvar AJ | title = Fecal enema as an adjunct in the treatment of pseudomembranous enterocolitis | journal = Surgery | volume = 44 | issue = 5 | pages = 854–859 | date = November 1958 | pmid = 13592638 }}</ref> For over two decades, FMT has been provided as a treatment option at the Centre for Digestive Diseases in Five Dock, Australia, by Thomas Borody, the modern-day proponent of FMT. In May 1988 their group treated the first ulcerative colitis patient using FMT, which resulted in complete resolution of all signs and symptoms long-term.<ref name="ReferenceA"/> In 1989 they treated a total of 55 patients with constipation, diarrhea, abdominal pain, ulcerative colitis, and Crohn's disease with FMT. After FMT, 20 patients were considered "cured" and a further nine patients had a reduction in symptoms.<ref>{{cite journal | vauthors = Borody TJ, George L, Andrews P, Brandl S, Noonan S, Cole P, Hyland L, Morgan A, Maysey J, Moore-Jones D | title = Bowel-flora alteration: a potential cure for inflammatory bowel disease and irritable bowel syndrome? | journal = The Medical Journal of Australia | volume = 150 | issue = 10 | page = 604 | date = May 1989 | pmid = 2783214 | doi = 10.5694/j.1326-5377.1989.tb136704.x | s2cid = 1290460 }}</ref> Stool transplants are considered about 90 percent effective in those with severe cases of ''C. difficile'' colonization, in whom antibiotics have not worked.<ref name=Burke2013/>

The first randomized controlled trial in ''C. difficile'' infection was published in January 2013.<ref name="vanNood2013">{{cite journal | vauthors = van Nood E, Vrieze A, Nieuwdorp M, Fuentes S, Zoetendal EG, de Vos WM, Visser CE, Kuijper EJ, Bartelsman JF, Tijssen JG, Speelman P, Dijkgraaf MG, Keller JJ | title = Duodenal infusion of donor feces for recurrent Clostridium difficile | journal = The New England Journal of Medicine | volume = 368 | issue = 5 | pages = 407–415 | date = January 2013 | pmid = 23323867 | doi = 10.1056/NEJMoa1205037 | s2cid = 25879411 | doi-access = free }}</ref> The study was stopped early due to the effectiveness of FMT, with 81% of patients achieving cure after a single infusion and over 90% achieving a cure after a second infusion.

Since that time, various institutions have offered FMT as a therapeutic option for a variety of conditions.<ref name="ReferenceA"/>

== Society and culture == === Regulation === Interest in FMT grew in 2012 and 2013, as measured by the number of clinical trials and scientific publications.<ref name="FDA-struggles">{{cite news|title=FDA struggles to regulate fecal transplants|work=CBS News|agency=Associated Press|date=June 26, 2014|url=http://www.cbsnews.com/news/fda-struggles-to-regulate-fecal-transplants/|access-date=October 12, 2014|archive-date=October 19, 2014|archive-url=https://web.archive.org/web/20141019095735/http://www.cbsnews.com/news/fda-struggles-to-regulate-fecal-transplants/|url-status=live}}</ref>

In the United States, the FDA announced in February 2013 that it would hold a public meeting entitled "Fecal Microbiota for Transplantation" which was held on May 2–3, 2013.<ref>{{cite web|title=Public Workshop: Fecal Microbiota for Transplantation|publisher=Food and Drug Administration|date=March 10, 2014|url=https://www.fda.gov/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/ucm341643.htm|access-date=December 16, 2019|archive-date=April 6, 2017|archive-url=https://web.archive.org/web/20170406180139/https://www.fda.gov/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/ucm341643.htm}}</ref><ref>{{FedReg|78|12763}}, February 25, 2013</ref> In May 2013 the FDA also announced that it had been regulating human fecal material as a drug.<ref name="policy-how-to">{{cite news |title=Policy: How to regulate faecal transplants |vauthors=Smith MB, Kelly C, Alm EJ |work=Nature |date=February 19, 2014 |url=http://www.nature.com/news/policy-how-to-regulate-faecal-transplants-1.14720 |access-date=October 12, 2014 |archive-date=November 4, 2014 |archive-url=https://web.archive.org/web/20141104145738/http://www.nature.com/news/policy-how-to-regulate-faecal-transplants-1.14720 |url-status=live }}</ref> The American Gastroenterological Association (AGA), the American College of Gastroenterology (ACG), the American Society for Gastrointestinal Endoscopy (ASGE), and the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN) sought clarification, and the FDA Center for Biologics Evaluation and Research (CBER) stated that FMT falls within the definition of a biological product as defined in the Public Health Service Act and the definition of a drug within the meaning of the Federal Food, Drug, and Cosmetic Act.<ref name="aga-confirms"/> It argued since FMT is used to prevent, treat, or cure a disease or condition, and intended to affect the structure or any function of the body, "a product for such use" would require an Investigational New Drug (IND) application.<ref name="aga-confirms">{{citation|title=AGA Confirms IND is Required for Fecal Microbiota Transplantation|publisher=American Gastroenterological Association|date=May 6, 2013|url=http://www.gastro.org/advocacy-regulation/regulatory-issues/fecal-microbiota-transplant/aga-confirms-ind-is-required-for-fecal-microbiota-transplantation|archive-url=https://web.archive.org/web/20130510024145/http://www.gastro.org/advocacy-regulation/regulatory-issues/fecal-microbiota-transplant/aga-confirms-ind-is-required-for-fecal-microbiota-transplantation|archive-date=May 10, 2013}}</ref>

In July 2013, the FDA issued an enforcement policy ("guidance") regarding the IND requirement for using FMT to treat ''C. difficile'' infection unresponsive to standard therapies ({{FedReg|78|42965}}, July 18, 2013).<ref name=fda713>{{cite web|title=Guidance for Industry: Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation to Treat Clostridium difficile Infection Not Responsive to Standard Therapies|publisher=Food and Drug Administration|date=July 2013|url=https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Vaccines/ucm361379.htm|access-date=December 16, 2019|archive-date=December 3, 2017|archive-url=https://web.archive.org/web/20171203015859/https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Vaccines/ucm361379.htm}}</ref>

In March 2014, the FDA issued a proposed update (called "draft guidance") that, when finalized, is intended to supersede the July 2013 enforcement policy for FMT to treat ''C. difficile'' infections unresponsive to standard therapies. It proposed an interim discretionary enforcement period, if 1) informed consent is used, mentioning investigational aspect and risks, 2) stool donor is known to either the person with the condition or physician, and 3) stool donor and stool are screened and tested under the direction of the physician ({{FedReg|79|10814}}, February 26, 2014).<ref name=fda313>{{cite web|title=Draft Guidance for Industry: Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation to Treat Clostridium difficile Infection Not Responsive to Standard Therapies|publisher=Food and Drug Administration|date=March 2014|url=https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Vaccines/ucm387023.htm|access-date=December 16, 2019|archive-date=June 5, 2018|archive-url=https://web.archive.org/web/20180605230853/https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Vaccines/ucm387023.htm}}</ref> Some doctors and people who want to use FMT have been worried that the proposal, if finalized, would shutter the handful of stool banks which have sprung up, using anonymous donors and ship to providers hundreds of miles away.<ref name="FDA-struggles"/><ref>{{cite news|vauthors=Emanuel G|title=MIT Lab Hosts Nation's First Stool Bank, But Will It Survive?|publisher=WBUR-FM|date=March 7, 2014|url=http://commonhealth.wbur.org/2014/03/first-stool-bank-survive|access-date=October 13, 2014|archive-date=October 17, 2014|archive-url=https://web.archive.org/web/20141017041225/http://commonhealth.wbur.org/2014/03/first-stool-bank-survive|url-status=live}}</ref><ref>{{cite journal | vauthors = Ratner M | title = Fecal transplantation poses dilemma for FDA | journal = Nature Biotechnology | volume = 32 | issue = 5 | pages = 401–402 | date = May 2014 | pmid = 24811495 | doi = 10.1038/nbt0514-401 | s2cid = 205268072 }}</ref>

{{As of|2015}}, FMT for recurrent ''C. difficile'' infections can be done without mandatory donor and stool screening, whereas FMT for other indications cannot be performed without an IND.<ref name="policy-how-to"/>

The FDA has issued three safety alerts regarding the transmission of pathogens. The first safety alert, issued in June 2019, described the transmission of a multidrug resistant organism from a donor stool that resulted in the death of one person.<ref>{{cite web|url=https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/important-safety-alert-regarding-use-fecal-microbiota-transplantation-and-risk-serious-adverse|title=Important Safety Alert Regarding Use of Fecal Microbiota for Transplantation and Risk of Serious Adverse Reactions Due to Transmission of Multi-Drug Resistant Organisms|website=U.S. Food and Drug Administration (FDA)|date=December 20, 2019|access-date=April 13, 2020|archive-date=May 6, 2020|archive-url=https://web.archive.org/web/20200506075808/https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/important-safety-alert-regarding-use-fecal-microbiota-transplantation-and-risk-serious-adverse}}</ref> The second safety alert, issued in March 2020, was regarding FMT produced from improperly tested donor stools from a stool bank which resulted in several hospitalizations and two deaths.<ref>{{cite web|url=https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/safety-alert-regarding-use-fecal-microbiota-transplantation-and-risk-serious-adverse-events-likely|title=Safety Alert Regarding Use of Fecal Microbiota for Transplantation and Risk of Serious Adverse Events Likely Due to Transmission of Pathogenic Organisms|author=Center for Biologics Evaluation and Research|date=March 12, 2020|website=U.S. Food and Drug Administration (FDA)|via=www.fda.gov|access-date=April 13, 2020|archive-date=May 30, 2020|archive-url=https://web.archive.org/web/20200530042716/https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/safety-alert-regarding-use-fecal-microbiota-transplantation-and-risk-serious-adverse-events-likely|url-status=live}}</ref> A safety alert in late March 2020, was due to concerns of transmission of COVID-19 in donor stool.<ref>{{cite web|url=https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/safety-alert-regarding-use-fecal-microbiota-transplantation-and-additional-safety-protections|title=Safety Alert Regarding Use of Fecal Microbiota for Transplantation and Additional Safety Protections Pertaining to SARS-CoV-2 and COVID-19|website=U.S. Food and Drug Administration (FDA)|date=April 9, 2020|access-date=April 13, 2020|archive-date=April 14, 2020|archive-url=https://web.archive.org/web/20200414041800/https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/safety-alert-regarding-use-fecal-microbiota-transplantation-and-additional-safety-protections|url-status=live}}</ref>

In November 2022, the Australian Therapeutic Goods Administration approved faecal microbiota under the brand name Biomictra,<ref name="Faecal microbiota" /><ref name="BiomeBank PR">{{cite press release | title=BiomeBank announces world first regulatory approval for donor derived microbiome drug | website=Biome Bank | date=November 9, 2022 | url=https://www.biomebank.com/news/biomebank-announces-world-first-regulatory-approval-for-donor-derived-microbiome-drug/ | access-date=January 2, 2024 | archive-date=January 2, 2024 | archive-url=https://web.archive.org/web/20240102051610/https://www.biomebank.com/news/biomebank-announces-world-first-regulatory-approval-for-donor-derived-microbiome-drug/ | url-status=live }}</ref> and the US FDA approved a specific ''C. difficile'' fecal microbiota treatment under the brand name Rebyota,<ref name="Ferring PR" /> administered rectally. In April 2023, the FDA approved a live spore capsule that can be taken by mouth, under the brand name Vowst.<ref name="FDA PR 20230427" /><ref>{{cite web | title=Gut check: The FDA approves microbiome-based therapies, with future approvals expected | website=Nixon Peabody LLP | date=May 15, 2023 | url=https://www.nixonpeabody.com/insights/alerts/2023/05/15/fda-approves-microbiome-based-therapies | access-date=January 2, 2024 | archive-date=January 2, 2024 | archive-url=https://web.archive.org/web/20240102051609/https://www.nixonpeabody.com/insights/alerts/2023/05/15/fda-approves-microbiome-based-therapies | url-status=live }}</ref>

=== Stool banks === In 2012, a team of researchers from the Massachusetts Institute of Technology founded OpenBiome, the first public stool bank in the United States.<ref>{{cite news |url=https://www.nytimes.com/2014/02/18/health/a-new-kind-of-transplant-bank.html |title=A New Kind of Transplant Bank |vauthors=Smith PA |work=The New York Times |date=February 17, 2014 |access-date=July 10, 2014 |archive-date=October 14, 2014 |archive-url=https://web.archive.org/web/20141014014447/http://www.nytimes.com/2014/02/18/health/a-new-kind-of-transplant-bank.html |url-status=live }}</ref>

Across Europe, numerous stool banks have emerged to serve the increasing demand. While consensus exists,<ref name="Cammarota2017" /> standard operation procedures still differ. Institutions in the Netherlands have published their protocols for managing FMT,<ref name="Terveer2017"/> and in Denmark institutions manages FMT according to the European Tissue and Cell directive.<ref name="Jorgensen2017"/>

=== Names === Previous terms for the procedure include ''fecal bacteriotherapy'', ''fecal transfusion'', ''fecal transplant'', ''stool transplant'', ''fecal enema'', and ''human probiotic infusion'' (''HPI''). Because the procedure involves the complete restoration of the entire fecal microbiota, not just a single agent or combination of agents, these terms have been replaced by the term ''fecal microbiota transplantation''.<ref name="Bakken"/>

== Research == Cultured intestinal bacteria are being studied as an alternative to fecal microbiota transplant.<ref>{{cite journal | vauthors = Dupont HL | title = Diagnosis and management of Clostridium difficile infection | journal = Clinical Gastroenterology and Hepatology | volume = 11 | issue = 10 | pages = 1216–23; quiz e73 | date = October 2013 | pmid = 23542332 | doi = 10.1016/j.cgh.2013.03.016 | doi-access = free }}</ref> One example is the rectal bacteriotherapy (RBT), developed by Tvede and Helms, containing 12 individually cultured strains of anaerobic and aerobic bacteria originating from healthy human faeces.<ref>{{cite journal | vauthors = Tvede M, Tinggaard M, Helms M | title = Rectal bacteriotherapy for recurrent Clostridium difficile-associated diarrhoea: results from a case series of 55 patients in Denmark 2000-2012 | journal = Clinical Microbiology and Infection | volume = 21 | issue = 1 | pages = 48–53 | date = January 2015 | pmid = 25636927 | doi = 10.1016/j.cmi.2014.07.003 | doi-access = free }}</ref> Research has also been done to identify the most relevant microbes within fecal transplants, which could then be isolated and manufactured via industrial fermentation; such standardized products would be more scalable, would reduce the risk of infections from unwanted microbes, and would improve the scientific study of the approach, since the same substance would be administered each time.<ref name="pmid23639085">{{cite journal | vauthors = Allen-Vercoe E, Petrof EO | title = Artificial stool transplantation: progress towards a safer, more effective and acceptable alternative | journal = Expert Review of Gastroenterology & Hepatology | volume = 7 | issue = 4 | pages = 291–293 | date = May 2013 | pmid = 23639085 | doi = 10.1586/egh.13.16 | s2cid = 46550706 | doi-access = free | author-link1 = Emma Allen-Vercoe }}</ref>

== Veterinary use == Elephants, hippos, koalas, and pandas are born with sterile intestines, and to digest vegetation need bacteria which they obtain by eating their mothers' feces, a practice termed coprophagia. Other animals eat dung.<ref>{{cite web |url=https://www.bbc.co.uk/nature/adaptations/Coprophagia |title=BBC Nature – Dung eater videos, news and facts |publisher=Bbc.co.uk |date=n.d. |access-date=November 27, 2011 |archive-date=December 29, 2011 |archive-url=https://web.archive.org/web/20111229185647/http://www.bbc.co.uk/nature/adaptations/Coprophagia }}</ref>

In veterinary medicine, fecal microbiota transplant is known as transfaunation and is used to treat ruminating animals, like cows and sheep, by feeding rumen contents of a healthy animal to another individual of the same species in order to colonize its gastrointestinal tract with normal bacteria.<ref name=peters>{{cite journal | vauthors = DePeters EJ, George LW | title = Rumen transfaunation | journal = Immunology Letters | volume = 162 | issue = 2 Pt A | pages = 69–76 | date = December 2014 | pmid = 25262872 | doi = 10.1016/j.imlet.2014.05.009 }}</ref>

== References == {{Reflist}}

== Further reading == {{wikispecies|Microbiota}} * {{cite journal | vauthors = Bibbò S, Ianiro G, Gasbarrini A, Cammarota G | title = Fecal microbiota transplantation: past, present and future perspectives | journal = Minerva Gastroenterologica e Dietologica | volume = 63 | issue = 4 | pages = 420–430 | date = December 2017 | pmid = 28927251 | doi = 10.23736/S1121-421X.17.02374-1 }} * {{cite journal | vauthors = El-Salhy M, Patcharatrakul T, Gonlachanvit S | title = Fecal microbiota transplantation for irritable bowel syndrome: An intervention for the 21st century | journal = World Journal of Gastroenterology | volume = 27 | issue = 22 | pages = 2921–2943 | date = June 2021 | pmid = 34168399 | pmc = 8192290 | doi = 10.3748/wjg.v27.i22.2921 | doi-access = free }}

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