Actively Recruiting
Synbiotics and Fecal Microbiota Transplantation to Treat Non-Alcoholic Steatohepatitis
Led by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Updated on 2024-08-27
48
Participants Needed
1
Research Sites
178 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Synbiotics and Fecal Microbiota Transplantation to Treat Non-Alcoholic Steatohepatitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Biopsy-proven NASH obtained up to 32 weeks before screening with SAF Steatosis score 651, Activity 652, Fibrosis <4; at least 50% must have NASH fibrosis stage 1, 2, or 3
- Ability to understand Dutch or English
- Ability to provide informed consent
You will not qualify if you...
- Significant alcohol consumption (>2 units/day for females, >3 units/day for males) for more than 3 consecutive months within 1 year before screening
- Presence of liver cirrhosis or hepatocellular carcinoma
- Infection with hepatitis B or C
- Auto-immune hepatitis
- Wilson's disease
- Primary sclerosing cholangitis
- Primary biliary cholangitis
- Alpha-1-antitripsine deficiency or hemochromatosis
- History of liver transplant or current placement on a liver transplant list
- Use of pre-, pro-, or synbiotics
- Use of systemic antibiotics within 3 months before randomization
- Use of tamoxifen, methotrexate, or amiodarone
- Prior or planned bariatric surgery
- Active diabetes mellitus treated with GLP-1 receptor agonists
- Bleeding disorders
- INR of prothrombin time >1.4 or platelet count <100 x 10^9/L at screening
- Use of anti-platelet or coagulant therapy that cannot be temporarily stopped
- Major cardiovascular event within 6 months before screening
- Prolonged compromised immunity, including recent chemotherapy or HIV with CD4 count <240
- Active or prior invasive malignancy except for certain treated in situ carcinomas or non-melanoma skin cancer
- Surgery planned during the trial period except minor procedures
- Pregnant or nursing women
- Any condition that may jeopardize safety or protocol compliance
- Participation in another clinical trial during this study period
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Amsterdam UMC
Amsterdam, North Holland, Netherlands, 1105AZ
Actively Recruiting
Research Team
Q
Quinten Augustijn, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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