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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 compared to placebo for non-alcoholic steatohepatitis (NASH) patients with mild or severe fibrosis.
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 major contributing role in the development of NASH with leaky gut, inflammation, oxidative stress and impaired microbiota. Restoring the microbiota symbiosys could be a new way of resolution of NASH.
The aim of this trial is to evaluate the efficacy of the Combo, association of probiotics (Lactobacillus rhamnosus GG, Bifidobacterium breve BR03, Lactobacillus plantarum) and Glutamine, Quercetin, Vitamin E, Curcumin, Silybin, Pectin by means of histological resolution of NASH without progression of fibrosis, after 26 weeks (6 months), in 60 NASH patients with mild to severe fibrosis.
To confirm a histological diagnosis of NASH and proof efficacy of the Combo, a liver biopsy will be performed prior to screening as well as at the end of supplemental phase
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment with Combo | Active Comparator | 3 dietary supplements will be given |
|
| Treatment with Placebo | Placebo Comparator | 3 placebos will be given |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment with Combo | Dietary Supplement | Treatment with Combo |
| |
| Measure | Description | Time Frame |
|---|---|---|
| NASH reduction: the main expected benefit is resolution of NASH, and no worsening of fibrosis | Evolution of the SAF score and CAP elastometry, a composite histological score taking into account the improvement of Steatosis, histological activity and liver fibrosis | At 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Initial correlation of NASH parameters (FIB4, NAFLD and liver stiffness) and symbiosis parameters (stool analysis by Shallow Shotgun, biological data specific to symbiosis). | At the screening | |
| Follow up of transaminase levels | At 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Follow up of Biological Scores (FIB4, NAFLD) throughout the study | At 6 months | |
| Follow up of symbiosis throughout the study, analysis of stool of the microbiota and measurement of the biological parameters of the symbiosis; correlation with the evolution of NASH. |
Inclusion Criteria:
Diagnosis of moderate to severe NASH :
Adults
Affiliated to a social security
Women using effective contraception (hormonal or mechanical) for the duration of the srudy
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Isabelle ROSA, Ph D | Contact | 01 57 02 27 30 | isabelle.rosa@chicreteil.fr | |
| Luc LEITZ | Contact | luc.heitz@mativa-tech.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Intercommunal Créteil | Recruiting | Créteil | 94010 | France |
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| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Treatment with placebo |
| Other |
Treatment with placebo |
|
| Reduction of hepatic steatosis measured by CAP elastometry and Hepatic MRI | At 6 months |
| At 6 months |
| Follow up of metabolic syndrome settings throughout the study : weight, waistline, blood pressure, Glycemia, Insulinemia, Gycated Hemoglonin level, Ferritinaemia, Triglyceridemia, HDL Cholesterol, LDL Cholesterol, Apolipoproteine A1, Homa score. | At 6 months |
| Centre Hospitalier Intercommunal de Villeneuve St Georges | Recruiting | Villeneuve-Saint-Georges | 94190 | France |
|