Synbiotics and Conditioned Fecal Microbiota Transplantation to Treat Non-Alcoholic Steatohepatitis.

Phase 2

Recruiting

• Conditions: non-alcoholic fatty liver disease; non-alcoholic steatohepatitis; 10019654

• Registration Number: NL-OMON51470
• Lead Sponsor: Amsterdam UMC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 52

Inclusion Criteria

- age 18-75 years
- 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
- subjects 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 units/day for females and more than 3
units/day for males, on average)
- 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
- 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
subject*s safety or compliance with the protocol,
- participation in another concomitant clinical trial.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Improvement of liver histology in subjects with NASH and fibrosis stage 0-3,<br /><br>with improvement defined as reduction of steatohepatitis by >=1 SAF-A point and<br /><br>no worsening of liver fibrosis, or improvement in >= 1 stage liver fibrosis and<br /><br>no worsening of steatohepatitis.</p><br>