Fecal microbiota transplantation (FMT) also known as a stool transplant is the process of transplantation of fecal bacteria from a healthy individual into a recipient. FMT involves restoration of the colonic microflora by introducing healthy bacterial flora through infusion of stool, e.g. by enema, orogastric tube or orally in the form of a capsule containing freeze dried material, obtained from a healthy donor. A limited number of studies have shown it to be an effective treatment for patients suffering from Clostridium difficile infection (CDI), which can range from diarrhea to pseudomembranous colitis. Due to an epidemic of CDI in North America and Europe, FMT has gained increasing prominence, with some experts calling for it to become first-line therapy for CDI. In 2013 a randomized, controlled trial of FMT from healthy donors showed it to be highly effective in treating recurrent C. difficile in adults, and more effective than vancomycin alone. 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. In the United States, the Food and Drug Administration (FDA) has regulated human faeces as an experimental drug since 2013.
- 1 Definition
- 2 Technique
- 3 Use by indication
- 4 History
- 5 In animals
- 6 Theoretical basis
- 7 Regulation
- 8 See also
- 9 References
- 10 External links
Fecal microbiota transplantation or FMT is the transfer of fecal material containing bacteria and natural antibacterials from a healthy individual into a diseased recipient. 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restoration of the entire fecal microbiota, not just a single agent or combination of agents, these terms have now been replaced by the new term 'Fecal Microbiota Transplantation'.
A team of international gastroenterologists and infectious disease specialists have published formal standard practice guidelines for performing FMT which outline in detail the FMT procedure, including preparation of material, donor selection and screening, and FMT administration.
Preparing for the procedure requires careful selection and screening of the donor and excluding those who test positive for certain diseases as well as any donor carrying any pathogenic gastrointestinal infectious agent.[vague]Although a close relative is often the easiest donor to obtain and have tested, there is no reason to expect this to affect the success of the procedure as genetic similarities or differences do not appear to play a role; Indeed, in some situations a close relative may be an asymptomatic carrier of C.difficile, a disadvantage. Donors must be tested for a wide array of bacterial and parasitic infections. In more than 370 published reports there has been no reported infection transmission.
Approximately 200-300 grams of fecal material is recommended per treatment[which?] for optimum results. Fresh stools have been recommended to be used within six hours, however frozen stool samples can also be used without loss of efficacy. There is evidence that the relapse rate is 2 fold greater when water is used as opposed to saline as the dilution agent. There is also some evidence that using infusions of greater than 500 ml produces a higher success rate compared to infusions using less than 200 ml of prepared solution. Research is needed to determine whether certain mixing methods such as using an electric blender reduce the efficacy of treatment via oxygenating the solution and killing obligate anaerobes. The fecal transplant material is then prepared and administered in a clinical environment to ensure that precautions are taken.
Numerous techniques have been published, and choice depends on suitability and ease. The procedure involves single to multiple infusions of bacterial fecal flora originating from a healthy donor by enema, through the colonoscope, or through a nasogastric or nasoduodenal tube. There does not appear to be any significant methodological difference in efficacy between the various routes. Repeat stool testing should be performed on patients to confirm eradication of CDI.[dubious ]
Autologous restoration of gastrointestinal flora
A modified form of fecal bacteriotherapy (Autologous Restoration of Gastrointestinal Flora - ARGF) was being developed as of 2009[update]. An autologous fecal sample, provided by the patient before anticipated medical treatment with antibiotics, is stored in a refrigerator. Should the patient subsequently develop C. difficile infection the sample is extracted with saline and filtered. The filtrate is freeze-dried and the resulting solid enclosed in enteric-coated capsules. Administration of the capsules is hypothesised to restore the patient's original colonic flora and combat C. difficile. However using one's own original colonic flora which made them susceptible to the CDI infection in the first place obviously holds a foreseeable disadvantage. As such, it is likely that following treatment the patient will still remain susceptible to C. difficile colonisation. In comparison, the introduction of donor flora facilitates colonisation with a more robust, C. difficile-resistant flora.
Researchers have also produced a standardised filtrate composed of viable fecal bacteria in a colourless, odourless form. The preparation has been shown to be as effective at restoring missing and deficient bacterial constituents as crude homogenised FMT.
Public stool bank in the U.S.
In 2012, a team of MIT researchers founded OpenBiome, the first public stool bank in the U.S. OpenBiome provides clinicians with frozen, ready-to-administer stool samples for use in treating C. difficile, and supports clinical research into the use of FMT for other indications.
Use by indication
In Clostridium difficile infection
Clostridium difficile infection (CDI) produces effects ranging from diarrhea to pseudomembranous colitis.Beginning in 2000, hypervirulent strains of C. difficile have emerged, which seem to be linked to commonly used broad acting antibiotics that are prescribed empirically. As of 2009[update] an estimated 3 million new acute Clostridium difficile infections were diagnosed in the US annually. Of these, a subgroup will go on to develop fulminant CDI which results in approximately 300 deaths per day or almost 110,000 deaths per year. This epidemic of CDI in North America and Europe, has made FMT increasingly attractive, with some experts calling for it to become first-line therapy for CDI.
The original cause of CDI is damage of the normal human flora and removal of protective Bacteroidetes and Firmicutes species. FMT restores the colonic microbiota to its natural state by replacing missing Bacteroidetes and Firmicutes species, eradicates C. difficile including its spores, and resolves clinical symptoms such as diarrhea, cramping, and urgency. Antibiotic resistance in CDI is an uncommon event- rather CDI relapses due to the presence of C. difficile spores. Anecdotal reports had shown FMT to be an effective treatment for patients with recurrent CDI. Most patients with CDI recover clinically and their CDI is eradicated after just one treatment.
A 2009 study found that fecal bacteriotherapy was an effective and simple procedure that was more cost-effective than continued antibiotic administration and reduced the incidence of antibiotic resistance.
In 2013, a randomized, controlled trial of FMT published in the New England Medical Journal in January 2013 reported a 94% cure rate of pseudomembranous colitis caused by Clostridium difficile in adults,compared to just 31% with Vancomycin alone. The study was stopped prematurely as it was considered unethical not to offer the FMT to all participants of the study due to the outstanding results.
once considered to be "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 have been moving toward acceptance of FMT as standard therapy for relapsing CDI and also Medicare coverage in the United States.
It has now[when?] been recommended that endoscopic FMT be elevated to first-line treatment for patients with clinical deterioration and severe relapsing C. difficile infection. The earlier the infusion is initiated, the less likely the patient's condition will deteriorate, thereby preventing the higher mortality rate associated with severely affected patients. Fecal Microbiota Transplantation is being increasingly used in clinical practice and, since complications of FMT are rare, its use is likely to increase.
In ulcerative colitis and other gastrointestinal conditions
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'.
In autoimmune and neurologic conditions
The therapeutic potential of FMT in non-gastroenterologic conditions, including autoimmune disorders, neurological conditions, obesity, metabolic syndrome and diabetes, Multiple Sclerosis, and Parkinson's diseaseare now being explored. As of May 2008[update], studies had shown that FMT can have a positive effect on devastating neurological diseases such as Parkinson's disease. While Dr. Thomas Borody was experimenting with patients who were afflicted by both CDI and Parkinson's disease, he realized that after fecal therapy the symptoms of Parkinson's in his patients began to decrease; some to the point that the Parkinson's could not be detected by other neurologists. The hypothesis for future studies is that the fluctuation in the body's microbiome done by FMT can also be recreated by adding anti-Clostridium difficile antibodies to the patient's body a technique intended to be used in Borody's future case studies involving Parkinson's disease.
The concept of treating fecal diseases with fecal matter originated in China millennia ago. Fourth century Chinese medical literature mentions it to treat food poisoning and severe diarrhea. 1200 years later Li Shizhen used yellow soup aka golden syrup which contained fresh dry or fermented stool to treat abdominal diseases.'Yellow soup' was made of fecal matter and water, which was drunk by the patient.
The consumption of "fresh, warm camel feces has been recommended by Bedouins as a remedy for bacterial dysentery; its efficacy probably attributable to the antimicrobial subtilisin produced byBacillus subtilis was anecdotally confirmed by German soldiers of the Afrika Korps during World War II".
The first description of FMT was published in 1958 by Ben Eiseman and colleagues, a team of surgeons from Colorado, who treated four critically ill patients with fulminant pseudomembranous colitis (before C.difficile was the known cause) using fecal enemas, which resulted in a rapid return to health. Stool transplants, are about 90% effective in those with severe cases of Clostridium difficile colonization, in whom antibiotics have not worked.
Since that time various institutions have offered the treatment as a therapeutic option for a variety of conditions. At the Centre for Digestive Diseases in Sydney Australia, FMT has been offered as a treatment options for more than 20 years. In May 1988 the CDD treated the first idiopathic colitis patient with FMT which resulted in a durable clinical and histological cure. Since that time, a number of publications have reported the successful treatment of UC with FMT, with clinical trials now underway in this indication.
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. Many other vegetarian mammals eat dung "because it's so hard to extract nourishment from their nutrient-poor diet".
In veterinary medicine fecal bacteriotherapy has been known as 'transfaunation' and is used to treat ruminating animals, like cows and sheep, by feeding rumen of a healthy animal to another individual of the same species in order to colonize its gastrointestinal tract with normal bacteria.
The hypothesis behind fecal bacteriotherapy rests on the concept of bacterial interference, i.e. using harmless bacteria to displace pathogenic organisms.In the case of CDI, the C.difficile pathogen is identifiable. However in the case of other conditions such as ulcerative colitis, no single 'culprit' has yet been identified.
In patients with relapsing CDI, the mechanism of action may be the restoration of missing components of the flora including Bacteroidetes and Firmicutes. The introduction of normal flora results in durable implantation of these components.
Another postulated mechanism entails the production of antimicrobial agents (Bacteriocins) by the introduced colonic flora to eradicate C. difficile. This may be a similar mechanism to that of Vancomycin which originates from soil bacteria, and Bacillus thuringiensis which has been proven to produce bacteriocins specific for C. difficile. The potential combination of replacing missing components and antimicrobial products manufactured by the incoming flora are likely to be the mechanisms curing CDI.
In the case of ulcerative colitis, it is likely that a shared infectious mechanism is at play, where the offending infective agent/s are still unknown. Given the response to FMT, it is scientifically plausible that an infection persists but cannot be identified.
Interest in FMT as measured by the number of clinical trials and scientific publictaions surged in 2012 and 2013. After the first rigorous, head-to-head study (randomized controlled trial) published January 2013 showed FMT was superior to antibiotics for patients with recurring C. difficile, the FDA announced in February 2013 to hold a public meeting entitled "Fecal Microbiota for Transplantation". At the meeting held on 2-3 May 2013 the FDA announced that it had been regulating human faeces as a drug. 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 (42 U.S.C. § 262(i)) and the definition of a drug within the meaning of the Federal Food, Drug, and Cosmetic Act (FDCA; 21 U.S.C. § 321(g)). 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 application (IND; regulations at 21 C.F.R. 312).
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 (78 F.R. 42965, 18 July 2013).
In February 2014, a gastroenterologist, a biological engineering professor from Massachusetts Institute of Technology (MIT) and an MIT microbiology PhD candidate, with the latter 2 being co-founders of the stool bank OpenBiome recommended that "for medical use, human stool should be considered a tissue, not a drug". They the strict requirements to protect patients,limited access to care. If stool was treated as a tissue product or given its own classification like blood, it would "keep patients safe, ensure broad access and facilitate research".
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 infection unresponsive to standard therapies. It announced an interim discretionary enforcement period, if 1) informed consent is used, mentioning investigational aspect and risks 2) stool donor is known to either patient or physician and 3) if stool donor and stool are screened and tested "under the direction of the physician" (79 F.R. 10814, 26 February 2014).
Some doctors and patients 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.
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