Synbiotics and Fecal Microbiota Transplantation to Treat Non-Alcoholic Steatohepatitis

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.

Conditions

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

Interventions

COMBINATION_PRODUCT

Lyophilized fecal microbiota transplantation capsules

Oral administration (capsule)

COMBINATION_PRODUCT

Placebo capsules

Oral administration (capsule)

DIETARY_SUPPLEMENT

A. soehngenii

Oral administration (capsule)

DIETARY_SUPPLEMENT

Pasteurized A. muciniphila

Oral administration (capsule)

DIETARY_SUPPLEMENT

B. animalis subsp. lactis

Oral administration (capsule)

DIETARY_SUPPLEMENT

Fructo-oligosaccharides

Oral administration (dissolved in water)

Sponsors & Collaborators

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

  lead OTHER

Principal Investigators

• A.G. Holleboom, MD, PhD · Amsterdam UMC

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-03-17

Primary Completion

2026-02-20

Completion

2026-08-20

Countries

• Netherlands

Study Locations