Synbiotics and Fecal Microbiota Transplantation to Treat Non-Alcoholic Steatohepatitis

Recruiting Phase 2 Interventional Study
Non Alcoholic Steatohepatitis Non-Alcoholic Fatty Liver Disease Fecal Microbiota Transplantation FMT Prebiotics Probiotics Microbiome Intestinal Microbiome Gut Microbiome
Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
48 (estimated)
Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Other
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About This Trial
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 th…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * biopsy-proven NASH obtained up to 32 weeks before screening: SAF Steatosis score ≥1, Activity ≥2, Fibrosis \<4; 50% of participants should at least have NASH fibrosis stage 1, 2 or 3 according to the NASH CRN fibrosis staging system based on tandem reading of two expert liver …
Contacts

Quinten Augustijn, MD

+31205661267

q.j.augustijn@amsterdamumc.nl

CONTACT