Clinical Trial

Synbiotics and Fecal Microbiota Transplantation to Treat Non-Alcoholic Steatohepatitis

Study acronym: SYNCH
Recruiting Phase 2
View on ClinicalTrials.gov →
Record status
This record was last updated August 27, 2024 (before its estimated February 20, 2026 completion). Its status may not reflect the trial's current state.
Summary
The goal of this clinical trial is to investigate the therapeutic potential of A. soehngenii and pasteurized A. muciniphila combined with B. animalis subsp. lactis and fructo-oligosaccharides with and without conditioned vegan lyophilized fecal microbiota transplantation capsules to reduce NASH in patients with fibrotic NASH. The main questions to answer are: 1. Can NASH be treated by altering the gut microbiota using LFMT capsules? 2. Can NASH be treated using a syntrophic cocktail of synbiotics and will these strains strengthen the effect of FMT? 3. What are the underlying mechanism by which the aforementioned treatments attenuate NASH? Participants will be treated with FMT-capsules or placebo, and all participants will receive a cocktail of 3 strains of probiotics and one type of prebiotic.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2023-04-06.
Trial Details
NCT Number NCT05821010
Lead Sponsor Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Conditions Non Alcoholic Steatohepatitis, Non-Alcoholic Fatty Liver Disease, Fecal Microbiota Transplantation, FMT, Prebiotics, Probiotics, Microbiome, Intestinal Microbiome +1 more
Enrollment 48 participants
Start Date 2023-03-17
Primary Completion 2026-02-20 (estimated)
Study Completion 2026-08-20 (estimated)
Updated on ClinicalTrials.gov 2024-08-27