NCT05821010 Synbiotics and Fecal Microbiota Transplantation to Treat Non-Alcoholic Steatohepatitis
| NCT ID | NCT05821010 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
| Condition | Non Alcoholic Steatohepatitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 48 participants |
| Start Date | 2023-03-17 |
| Primary Completion | 2026-02-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 48 participants in total. It began in 2023-03-17 with a primary completion date of 2026-02-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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 pathologists * fluency in Dutch or English * participants should be able to understand the information and give informed consent Exclusion Criteria: * Current or history of significant alcohol consumption for a period of more than 3 consecutive months within 1 year before screening (significant alcohol consumption is defined as more than 2 international units/day for females and more than 3 international units/day for males, on average; 1 international unit contains ±14 grams of alcohol) * liver cirrhosis or hepatocellular carcinoma * hepatitis B and/or C * auto-immune hepatitis * Wilson's disease * primary sclerosing cholangitis * primary biliary cholangitis * alpha-1-antitripsine deficiency and hemochromatosis * history of liver transplant, current placement on a liver transplant list * use of pre-, pro- or synbiotics * use of systemic antibiotics 3 month prior to randomization * use of tamoxifen, methotrexate or amiodarone * prior or planned bariatric surgery * active GLP-1 receptor agonist treated diabetes mellitus * bleeding disorder * International normalized ratio (INR) of prothrombin time \>1.4 or platelet count \<100 109/L at screening * anti-platelet/coagulant therapy use which cannot be temporarily discontinued * any major cardiovascular event within 6 months prior to screening (e.g. myocardial infarction, cerebrovascular accident) * prolonged compromised immunity (e.g. recent cytotoxic chemotherapy, HIV-infection with a CD4 count \< 240) * active or prior history of invasive malignancy (except for curatively treated in situ carcinomas \[e.g., cervix\] or non-melanoma skin cancer) unless a complete remission was achieved * surgery scheduled for the trial duration period, except for minor surgical procedures, in the opinion of the investigator * pregnant or nursing women * any condition which, in the investigator's opinion, might jeopardize participants' safety or compliance with the protocol * participation in another concomitant clinical trial.
Contact & Investigator
A.G. Holleboom, MD, PhD
PRINCIPAL INVESTIGATOR
Amsterdam UMC
Frequently Asked Questions
Who can join the NCT05821010 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Non Alcoholic Steatohepatitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05821010 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05821010 currently recruiting?
Yes, NCT05821010 is actively recruiting participants. Contact the research team at q.j.augustijn@amsterdamumc.nl for enrollment information.
Where is the NCT05821010 trial being conducted?
This trial is being conducted at Amsterdam, Netherlands.
Who is sponsoring the NCT05821010 clinical trial?
NCT05821010 is sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA). The principal investigator is A.G. Holleboom, MD, PhD at Amsterdam UMC. The trial plans to enroll 48 participants.