Study of Synbiotics and Fecal Microbiota Transplantation Capsules to Treat Non-Alcoholic Steatohepatitis in Adults with Fibrotic NASH

What this Trial Is About

Researchers are studying the potential to treat Non-Alcoholic Steatohepatitis NASH and fibrotic NASH by altering the gut microbiota. This trial focuses on using a combination of specific probiotic strains A. soehngenii, pasteurized A. muciniphila, B. animalis subsp. lactis, and fructo-oligosaccharides, with or without conditioned vegan lyophilized fecal microbiota transplantation LFMT capsules. The study aims to answer whether these treatments can reduce NASH and to understand the mechanisms behind their effects. Participants will receive daily doses of the probiotic strains and prebiotic fructo-oligosaccharides starting three days before the first FMT treatment and continuing throughout the 24-week study. They will be randomly assigned to receive either LFMT capsules or placebo capsules, with dosing involving 21 capsules at baseline, week 8, and week 16, plus daily intake of 2 capsules during the study. The trial is designed as a double-blind, placebo-controlled intervention. During participation, patients will undergo liver biopsies at screening and after 24 weeks to assess liver histology. They will also provide feces and blood samples at multiple timepoints to study gut microbiome changes and liver-related biomarkers. Imaging tests including multiparametric MRI and Fibroscan will be done at baseline and after 24 weeks. Continuous glucose monitoring will be performed at home at several intervals. The study collects various health data to evaluate the interventions effects and monitor safety over the 24-week period.

Synbiotics and Fecal Microbiota Transplantation to Treat Non-Alcoholic Steatohepatitis