Interest in "Combo" (a Combination of Dietary Supplements Including Probiotics) in NASH Improvement

Launched by MATIVA-TECH SA · Mar 1, 2021

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a combination of dietary supplements, including probiotics, on patients with nonalcoholic steatohepatitis (NASH), a type of liver disease. The goal is to see if these supplements can help improve the condition compared to a placebo, which is a treatment that looks like the supplements but contains no active ingredients. The trial is currently recruiting participants aged 65 to 74, as well as younger adults who meet specific health criteria. To be eligible, participants must have been diagnosed with moderate to severe NASH and have certain liver stiffness levels.

Participants in this study can expect to be randomly assigned to receive either the Combo of dietary supplements or a placebo for the duration of the trial. This means that neither they nor the researchers will know which treatment they are receiving, helping to ensure the results are unbiased. It's important to note that certain health conditions, such as pregnancy, excessive alcohol consumption, or liver cirrhosis, may exclude individuals from participating. Overall, this trial aims to provide valuable information about how dietary supplements might improve liver health in people with NASH.

Gender

ALL

Eligibility 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