Combination of dietary supplements to improve liver health in NASH patients
Interest in "Combo" (a Combination of Dietary Supplements Including Probiotics) in NASH Improvement
This study is testing whether a mix of dietary supplements can improve liver health in people with non-alcoholic steatohepatitis (NASH) and fibrosis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Mativa-Tech SA Industry-sponsored |
| Drugs / interventions | Methotrexate |
| Locations | 2 sites (Créteil and 1 other locations) |
| Trial ID | NCT04781933 on ClinicalTrials.gov |
What this trial studies
This interventional study aims to evaluate the effects of a combination of dietary supplements, including probiotics and other compounds, on patients with non-alcoholic steatohepatitis (NASH) who have mild to severe fibrosis. The study is designed as a bicentre, placebo-controlled, double-blind, randomized trial, where participants will receive either the Combo or a placebo for 26 weeks. The primary outcome will be assessed through liver biopsies to determine histological resolution of NASH and the progression of fibrosis. The study seeks to address the lack of established pharmacotherapies for NASH by exploring the role of gut microbiota in liver health.
Who should consider this trial
Good fit: Ideal candidates include adults diagnosed with moderate to severe NASH and liver stiffness between 8 and 15 kPa.
Not a fit: Patients with cirrhosis, excessive alcohol consumption, or other significant liver diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a novel dietary approach to improve liver health and potentially reverse NASH in affected patients.
How similar studies have performed: While the approach of using dietary supplements in NASH is relatively novel, there is emerging interest in the role of gut microbiota in liver diseases, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of moderate to severe NASH : * chronic liver disease: biological abnormalities for more than 6 months characteristic ultrasound aspects * metabolic syndrome * liver stiffness assessed by FibroScan between 8 and 15kPa * Adults * Affiliated to a social security * Women using effective contraception (hormonal or mechanical) for the duration of the srudy Exclusion Criteria: * Pregnancy * Excessive alcohol consumption (\>100g/week) * Cirrhosis (elastometry \> 15kPa) * hepato-cellular carcinoma * Hepatitis from Corticosteroids, Methotrexate, Amiodarone, Tamoxifen * Viral hepatitis * Auto immune hepatitis * anticoagulant therapy * antibiotics in the month prior to inclusion * allergic to soya, aspirin, fish, E110 dye, Maltodextrin * poorly controlled diabetes (Glycated Hemoglobin \>8%) * inclusion in a drug interventional trial
Where this trial is running
Créteil and 1 other locations
- Centre Hospitalier Intercommunal Créteil — Créteil, France (Recruiting)
- Centre Hospitalier Intercommunal de Villeneuve St Georges — Villeneuve St Georges, France (Recruiting)
Study contacts
- Study coordinator: Isabelle ROSA, Ph D
- Email: isabelle.rosa@chicreteil.fr
- Phone: 01 57 02 27 30
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.