Actively Recruiting
Led by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Updated on 2024-08-27
48
Participants Needed
1
Research Sites
25 weeks
Total Duration
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 intervention's effects and monitor safety over the 24-week period.
CONDITIONS
Synbiotics and Fecal Microbiota Transplantation to Treat Non-Alcoholic Steatohepatitis
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - Up to 32 weeks before baseline
Participants are screened for eligibility to participate in the trial.
Percutaneous liver biopsy at screening if no biopsy performed within prior 36 weeks
Duration - 24 weeks
Participants receive daily oral prebiotics and probiotics with randomized assignment to lyophilized fecal microbiota transplantation (LFMT) capsules or placebo capsules, taken over 24 weeks.
Study visits at baseline, week 8, and week 16; daily capsule intake throughout
Duration - Assessment at 24 weeks after baseline
Participants undergo assessments to evaluate treatment effects including liver biopsy, MRI, and blood tests.
1 visit for liver biopsy and MRI at 24 weeks
Total: 1 location
1
Amsterdam UMC
Amsterdam, North Holland, Netherlands, 1105AZ
Actively Recruiting
Q
Quinten Augustijn, MD
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Quinten J J Augustijn, Aldo Grefhorst, Pleun de Groen...
https://pubmed.ncbi.nlm.nih.gov/39788762