Safety and Potential Risks with Fecal Microbiota Transplantation

Abstract

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.

Understanding the Role of the Gut Microbiome in Brain Development and Its Association With Neurodevelopmental Psychiatric Disorders

“…MTT in a clinical trial has been reported to improve GI symptoms such as indigestion, abdominal pain, constipation, and diarrhea and symptoms related to ASD and normalized any alteration in the gut microbiota in ASD patients (D. W. Kang et al, 2017 , 2019 ). Thus, there is increasing interest in using FMT and MTT as a therapeutic intervention for treating children with NDDs, following all the concerning safety issues ( Gaonkar, 2021 ).…”

Orchestrating the fecal microbiota transplantation: Current technological advancements and potential biomedical application

“…In the context of the recent SARS-CoV-2 outbreak, stringent policies are required for the screening of FMT donors to ensure patient safety. In this concern, FDA directed that further safety measures are required for any investigational use of FMT, whether under an Investigational New Drug Application (IND) on file with the FDA or under FDA's enforcement discretion policy ( 78 ).…”