Status:
UNKNOWN
Interest in "Combo" (a Combination of Dietary Supplements Including Probiotics) in NASH Improvement
Lead Sponsor:
Mativa-Tech SA
Conditions:
NASH - Nonalcoholic Steatohepatitis
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
The aim of this bicentre, prospective, placebo-controlled, double-blind, randomized, interventional study is to assess for the first time the effects of a Combo with probiotics and dietary supplements...
Detailed Description
Liver-related mortality is increased 10-fold in NASH patients compared with the general population. Currently, there are no established pharmacotherapies for NASH patients. The gut microbiota has a ma...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04781933
Start Date
January 1 2023
End Date
January 1 2025
Last Update
November 7 2023
Active Locations (2)
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1
Centre Hospitalier Intercommunal Créteil
Créteil, France, 94010
2
Centre Hospitalier Intercommunal de Villeneuve St Georges
Villeneuve-Saint-Georges, France, 94190