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.
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