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

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.

Study Overview

• Status: Recruiting
• Conditions: NASH - Nonalcoholic Steatohepatitis
• Intervention / Treatment: Dietary supplement: Treatment with Combo; Other: Treatment with placebo

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 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

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Luc LEITZ; Email: luc.heitz@mativa-tech.com
• Study Contact Backup: Name: Isabelle ROSA, Ph D; Phone Number: 01 57 02 27 30; Email: isabelle.rosa@chicreteil.fr

Study Locations

• France
  • Créteil, France, 94010
    • Recruiting
    • Centre Hospitalier Intercommunal Créteil
    • Contact: Isabelle ROSA, MD; Email: isabelle.rosa@chicreteil.fr
  • Villeneuve St Georges, France, 94190
    • Recruiting
    • Centre Hospitalier Intercommunal de Villeneuve St Georges
    • Contact: Armand GARIOUD, PhD; Email: armand.garioud@chiv.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
Reduction of hepatic steatosis measured by CAP elastometry and Hepatic MRI	At 6 months

Other Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Mativa-Tech SA

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Estimated): January 1, 2024
• Study Completion (Estimated): January 1, 2025

Study Registration Dates

• First Submitted: February 17, 2021
• First Submitted That Met QC Criteria: March 1, 2021
• First Posted (Actual): March 4, 2021

Study Record Updates

• Last Update Posted (Actual): November 7, 2023
• Last Update Submitted That Met QC Criteria: November 6, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: gut microbiota; dietary supplements; liver stiffness; Combo
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: ICAN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No