The efficacy and safety of fecal microbiota transplantation in the treatment of systemic sclerosis

Abstract

Background: Systemic sclerosis (SSc) is 1 of the most complex systemic autoimmune diseases.Accumulating evidence suggests that gut microbiota affect the development and function of the immune system and may play a role in the pathogenesis of autoimmune diseases. This new paradigm raises the possibility that many diseases result, at least partially, from microbiota-related dysfunction. This understanding invites the investigation of fecal microbiota transplantation (FMT) in the treatment of SSc. However, no study has specifically and systematically investigated the efficacy and safety of FMT in the treatment of SSc. Thus, this study will systematically and comprehensively appraise the efficacy and safety of FMT in the treatment of SSc. Methods: We will search the following sources without restrictions for date, language, or publication status: PubMed, Web of Science,Cochrane Central Register of Controlled Trials (CENTRAL) Cochrane Library, EMBASE and China National Knowledge Infrastructure. We will apply a combination of Medical Subject Heading (MeSH) and free-text terms incorporating database-specific controlled vocabularies and text words to implement search strategies. We will also search the ongoing trials registered in the World Health Organization's International Clinical Trials Registry Platform. Besides, the previous relevant reviews conducted on FMT for SSc and reference lists of included studies will also be searched. Results: This study will provide a reliable basis for the treatment of SSc with FMT. Conclusions: The findings will be an available reference to evaluate the efficacy and safety of FMT in the treatment of SSc. Registration number: INPLASY202060019.

YouTube as a source of information on systemic sclerosis

“…There are ongoing studies about feces transplantation, which has not been shown to be fully safe and long-term adverse reactions are also not known. 16,17 There were also advertisement videos for patients for gene therapy and stem cell transplantation. These were uploaded by health-related websites and directed the patients toward these treatment methods.…”

A meta-analysis of microbiome therapies for hepatic encephalopathy

“…The primary outcome of both trials assessed the safety of FMT and found no safety concerns except for a small reversible increase in Model for End-Stage Liver Disease (MELD) scores after broad-spectrum antibiotic treatment. A systematic review of FMT concluded that FMT is effective in treating and reducing the recurrence of HE [49]. Additionally, arterial ammonia levels were significantly reduced after FMT treatment.…”

Dysbiosis and Gut Microbiota Modulation in Systemic Sclerosis

“…Events range from mild to moderate manifestations, such as abdominal pain and cramps, to more severe occurrences, such as FMT procedure-related injuries, disseminated infections, autoimmune diseases development, and ultimately death. 59,60 Although there is considerable debate on how to improve safety of FMT, recommendations or guidelines for donor selection, frequency and route of administration, and management of adverse events, among other issues, are still under development. 61 A main concern is the possible transfer of pathogenic agents that could not be identified in screening tests and the development of severe infections.…”

“…Approximately 44% and 18% of adverse events are associated with upper and lower GI administration routes, respectively. Events range from mild to moderate manifestations, such as abdominal pain and cramps, to more severe occurrences, such as FMT procedure-related injuries, disseminated infections, autoimmune diseases development, and ultimately death 59,60 …”