Synbiotics and Fecal Microbiota Transplantation to Treat Non-Alcoholic Steatohepatitis

Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study ID
NCT05821010
Phase
PHASE2
Status
Recruiting
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Conditions

  • FMT
  • Fecal Microbiota Transplantation
  • Gut Microbiome
  • Intestinal Microbiome
  • Microbiome
  • Non Alcoholic Steatohepatitis
  • Non-Alcoholic Fatty Liver Disease
  • Prebiotics
  • Probiotics

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Lyophilized fecal microbiota transplantation capsules — COMBINATION_PRODUCT
    Oral administration (capsule)
  • Placebo capsules — COMBINATION_PRODUCT
    Oral administration (capsule)
  • A. soehngenii — DIETARY_SUPPLEMENT
    Oral administration (capsule)
  • Pasteurized A. muciniphila — DIETARY_SUPPLEMENT
    Oral administration (capsule)
  • B. animalis subsp. lactis — DIETARY_SUPPLEMENT
    Oral administration (capsule)
  • Fructo-oligosaccharides — DIETARY_SUPPLEMENT
    Oral administration (dissolved in water)

Study Details

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.

Key Dates

First listed
Apr 20, 2023
Start date
Mar 17, 2023
Status verified
Aug 2024
Primary completion
Feb 20, 2026
Completion
Aug 20, 2026

Study Design

Enrollment
48 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: LFMT-capsules
    LFMT-capsules. 3 times bulk, and further continuous administration. This arm is also treated pre- and probiotics.
  • Placebo Comparator: Placebo
    Placebo-capsules. 3 times bulk, and further continuous administration. This arm is also treated pre- and probiotics.

Primary Outcome Measure

Liver histology [ Time Frame: baseline and after 24 weeks ]

Central Contacts

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