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

NASH - Nonalcoholic Steatohepatitis Clinical Trial

— ICAN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04781933
• Other study ID #: ICAN
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: January 1, 2025

Study information

• Verified date: November 2023
• Source: Mativa-Tech SA
• Contact: Isabelle ROSA, Ph D
• Phone: 01 57 02 27 30
• Email: isabelle.rosa[@]chicreteil.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 compared to placebo for non-alcoholic steatohepatitis (NASH) patients with mild or severe fibrosis.

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 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: January 1, 2025
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatty Liver
• NASH - Nonalcoholic Steatohepatitis
• Non-alcoholic Fatty Liver Disease

Intervention

Dietary Supplement:
• Treatment with Combo
Treatment with Combo

Other:
• Treatment with placebo
Treatment with placebo

Locations

Country	Name	City	State
France	Centre Hospitalier Intercommunal Créteil	Créteil
France	Centre Hospitalier Intercommunal de Villeneuve St Georges	Villeneuve St Georges

Sponsors (1)

Lead Sponsor	Collaborator
Mativa-Tech SA

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Follow up of Biological Scores (FIB4, NAFLD) throughout the study		At 6 months
Other	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.		At 6 months
Other	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
Primary	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
Secondary	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
Secondary	Follow up of transaminase levels		At 6 months
Secondary	Reduction of hepatic steatosis measured by CAP elastometry and Hepatic MRI		At 6 months