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

Sponsor

Mativa-Tech SA (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT04781933

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
NASH - Nonalcoholic Steatohepatitis	Dietary Supplement: Treatment with Combo Other: Treatment with placebo	N/A

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 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 52 weeks, 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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Oct 1, 2021

Anticipated Primary Completion Date :

May 1, 2022

Anticipated Study Completion Date :

May 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Treatment with Combo 3 dietary supplements will be given	Dietary Supplement: Treatment with Combo Treatment with Combo
Placebo Comparator: Treatment with Placebo 3 placebos will be given	Other: Treatment with placebo Treatment with placebo

Arm

Intervention/Treatment

Active Comparator: Treatment with Combo

3 dietary supplements will be given

Dietary Supplement: Treatment with Combo

Treatment with Combo

Placebo Comparator: Treatment with Placebo

3 placebos will be given

Other: Treatment with placebo

Treatment with placebo

Outcome Measures

Primary Outcome Measures

NASH reduction: the main expected benefit is resolution of NASH, and no worsening of fibrosis [At one year]
Evolution of the SAF score, a composite histological score taking into account the improvement of Steatosis, histological activity and liver fibrosis. (Expected decrease in the median of 1.0; before treatment expected to 4.5 after expected treatment at 3.5), an improvement of 30%.

Secondary Outcome Measures

Initial correlation of NASH parameters (SAF, FIB4, NAFLD and liver stiffness) and symbiosis parameters (stool analysis 16S, biological data specific to symbiosis). [At the screening]
Follow up of liver stiffness throughout the study [At 6 months and 1 year]

Other Outcome Measures

Follow up of Biological Scores (FIB4, NAFLD) throughout the study [At 6 months and 1 year]
Follow up of symbiosis throughout the study, analysis of stool 16S of the microbiota and measurement of the biological parameters of the symbiosis; correlation with the evolution of NASH. [At 6 months and 1 year]
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 and 1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 > or at 8kPa. (10 measures validated with median IQR < 30%)
histologic evidence of NASH with fibrosis stage (METAVIR score) F2 or F3
Adults
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