Irritable bowel syndrome and transplantation of fecal microbiota. Review

Objective — to perform analysis of the literature data as regards the efficacy of the use of fecal microbiota transplantation (FMT) in patients with the irritable bowel syndrome (IBS). Materials and methods. The systematic review of the literature (PubMed, MEDLINE, Cochrane Library) has been performed to assess the results of investigation on the use of FMT in adult IBS patients. Results. Currently, FMT is a safe and highly successful method of treatment for recurrent Clostridium difficile infection, and possibility to use FMT in the treatment of other diseases is under investigation. The results of FMT treatment of patients with IBS are contradictory. A number of authors outline fairly high FMT efficacy when used for the treatment of patients with IBS, refractory to the standard methods: it varies from 36 % to 70 % with a duration of adequate symptoms’ relief up to 1 year. However, other authors indicate that the positive FMT clinical effect lasted from 8 weeks to 3 months, after which there was a gradual recovery of symptoms. At the same time, the researchers noted that mostly often the positive outcome was reached after FMT from donors with a higher number of streptococci in the feces. Still others point out that there was no sustained, at least 50‑point reduction in the severity of IBS symptoms from baseline. Some authors did not reveal the advantages of FMT over placebo control and even reported about the higher placebo efficacy. After data generalization no significant difference was revealed in the global improvement in IBS symptoms in patients receiving donor FM versus placebo. However, the attention is drawn to the relationship between the results of FMT with methodology. Indeed, several studies have shown that placebo capsules were more effective than capsules containing donor feces, whereas FMT from donor stool delivered by colonoscopy was superior to FMF from autologous stool. This may be due to the excipients, containing in the capsulated FMT. A number of researchers also indicated that the use of a super donor is necessary for successful FMT and that the response to FMT is dose dependent. Conclusions. To resolve the issue of the expediency of using FMT in routine clinical practice in patients with IBS, more qualitative controlled studies, involving large cohorts of IBS patients and long‑term follow‑up, are required.

Current status, complications and prospects of fecal microbiota transplantation therapy

Currently, the emergence of highly virulent mutants in Europe and the United States has caused refractory recurrent Clostridium difficile infection (RCDI) to be a problem in clinical practice. In 2013, the Netherland group demonstrated breakthrough therapeutic efficacy in fecal microbial transplant (FMT) treatment clinical trials for RCDI, and FMT treatment is rapidly gaining attention. In addition to RCDI, FMT treatment has been attempted in various gastrointestinal diseases such as inflammatory bowel disease, irritable bowel syndrome and chronic constipation, as well as extragastrointestinal diseases. In this review, I would like to describe the current status, complications and prospects of FMT treatment.

Safety and Potential Risks with Fecal Microbiota Transplantation

The therapeutic potential of Fecal Microbiota Transplantation (FMT) is greatly proved worldwide in the recent years. The use of FMT is now an accepted treatment modality and effective standard of care for some patients owing to its success in treating recurrent Clostridium Difficile Infection (rCDI). However, it is still evolving and longer term follow-up data regarding safety are required. Post-FMT serious adverse events (SAEs) have been varied between studies, however have included significant morbidity necessitating hospital admission and mortality in the follow-up period. The follow-up of FMT recipients should be long enough to completely establish efficacy/adverse events. Furthermore, it is recommended that FMT should be offered with caution to immunosuppressed patients, in whom FMT appears efficacious without significant additional adverse effects. In the wake of COVID-19 situation, stringent policies in screening the FMT donors have to be put forth to ensure patient safety. There is a need for high-quality, large, prospective, randomized controlled trials and long-term follow-up investigating screened donors and recipients to evaluate the long term safety and the risk–benefit profile of this promising therapy.

FECAL MICROBIOTES TRANSPLANTATION TECHNOLOGIES: MEDICAL, BIOTECHNOLOGICAL AND REGULATORY ASPECTS

Fecal microbiota transplantation (FMT) is a treatment method based on donor's fecal solution injection into the patient's gastrointestinal tract. FMT is effectively used in the treatment of recurrent Clostridium difficile infection. There is also growing interest in the therapeutic application of the method to treat metabolic, autoimmune and other disorders that was not previously associated with intestinal microbiota. Despite the promising results of FMT use, the organizational and legal matters and that of the safety FMT application have not yet been resolved in the European and Ukrainian medical community. The purpose of this review was to summarize information on the FMT application and the regulatory aspects of its use. The analysis of the practical instructions provisions of for FMT applying in clinical practice was carried out, and the bioethical problems associated with the FMT use were investigated.