Health TrialsbyHealthPanel

Synbiotics and Fecal Microbiota Transplantation to Treat Non-Alcoholic Steatohepatitis

ConditionsNon Alcoholic SteatohepatitisNon-Alcoholic Fatty Liver DiseaseFecal Microbiota TransplantationFMTPrebioticsProbioticsMicrobiomeIntestinal MicrobiomeGut Microbiome
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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 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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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)

Treatment groups

48 Participants
are divided into 2 treatment groups
Group A: LFMT-capsulesExperimental treatment 5 interventions
Group B: PlaceboPlacebo comparator 5 interventions

Trial outcomes

Primary outcomes

1

Liver histology

Alteration of liver histology in subjects with NASH and fibrosis stage 0-3, with an alteration defined as change of steatohepatitis by ≥1 SAF-A point, or a change in ≥ 1 stage liver fibrosis.

Time frame
baseline and after 24 weeks

Secondary outcomes

1

MRI

MRI-PDFF, MR elastography, corrected T1

Time frame
baseline and after 24 weeks
2

Fibroscan

CAP and LSM

Time frame
baseline and after 24 weeks
3

Liver enzymes (blood)

alanine amino transferase (ALT), aspartate amino transferase (AST), gamma glutamyl transferase (GGT), alkaline phosphatase (ALP))

Time frame
baseline and after 24 weeks; 8 and 16 weeks for safety.
4

Immunological data

leukocytes, monocytes, CRP, Il-1(β), Il-6, Il-11, Il-17, Il-32, TNF-α, IFN-γ, other inflammatory markers),

Time frame
baseline and after 24 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Lead sponsor

Source ClinicalTrials.gov
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