Synbiotics and Fecal Microbiota Transplantation to Treat Non-Alcoholic Steatohepatitis

Launched by ACADEMISCH MEDISCH CENTRUM - UNIVERSITEIT VAN AMSTERDAM (AMC-UVA) · Apr 6, 2023

Keywords

ClinConnect Summary

This clinical trial is exploring new ways to treat Non-Alcoholic Steatohepatitis (NASH), a condition where fat builds up in the liver, causing inflammation and scarring. Researchers want to see if using special capsules containing beneficial bacteria (called probiotics) and a specific treatment using processed fecal matter (known as fecal microbiota transplantation or FMT) can help improve liver health in patients with fibrotic NASH. The trial will test different combinations of these treatments to find out which is most effective.

To participate in the trial, you must be between 18 and 75 years old and have a confirmed diagnosis of NASH through a liver biopsy within the last 32 weeks. You should also be able to speak either Dutch or English and understand the trial information. Participants will either receive the treatment capsules or a placebo (a dummy treatment) along with a mix of probiotics and prebiotics. If you qualify and join the study, you'll be closely monitored to see how your liver responds to the treatment. It’s important to note that certain health conditions, such as significant alcohol use or severe liver disease, may exclude you from participating.

Gender

ALL

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.