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

Primary Purpose

NASH - Nonalcoholic Steatohepatitis

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Treatment with Combo
Treatment with placebo
Sponsored by
Mativa-Tech SA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for NASH - Nonalcoholic Steatohepatitis focused on measuring Combo, liver stiffness, gut microbiota, dietary supplements

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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
  • Affiliated to a social security

Exclusion Criteria:

  • Pregnancy
  • Excessive alcohol consumption (>100g/week)
  • Cirrhosis (F4)
  • hepato-cellular carcinoma
  • Hepatitis from Corticosteroids, Methotrexate, Amiodarone, Tamoxifen
  • Hepatitis from Amitriptyline, Imipramine, Clozapine, Diclofenac
  • Viral hepatitis
  • Auto immune hepatitis
  • anticoagulant therapy
  • antibiotics in the 2 months prior to inclusion
  • allergic to soya, aspirin, fish, E110 dye, Maltodextrin
  • poorly controlled diabetes (Glycated Hemoglobin >8%)
  • inclusion in a drug interventional trial

Sites / Locations

  • Centre Hospitalier Intercommunal CréteilRecruiting
  • Centre Hospitalier Intercommunal de Villeneuve St GeorgesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Treatment with Combo

Treatment with Placebo

Arm Description

3 dietary supplements will be given

3 placebos will be given

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Initial correlation of NASH parameters (FIB4, NAFLD and liver stiffness) and symbiosis parameters (stool analysis by Shallow Shotgun, biological data specific to symbiosis).
Follow up of transaminase levels
Reduction of hepatic steatosis measured by CAP elastometry and Hepatic MRI

Full Information

First Posted
February 17, 2021
Last Updated
October 20, 2023
Sponsor
Mativa-Tech SA
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1. Study Identification

Unique Protocol Identification Number
NCT04781933
Brief Title
Interest in "Combo" (a Combination of Dietary Supplements Including Probiotics) in NASH Improvement
Acronym
ICAN
Official Title
Interest in "Combo" (a Combination of Dietary Supplements Including Probiotics) in NASH Improvement
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
January 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mativa-Tech SA

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
NASH - Nonalcoholic Steatohepatitis
Keywords
Combo, liver stiffness, gut microbiota, dietary supplements

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment with Combo
Arm Type
Active Comparator
Arm Description
3 dietary supplements will be given
Arm Title
Treatment with Placebo
Arm Type
Placebo Comparator
Arm Description
3 placebos will be given
Intervention Type
Dietary Supplement
Intervention Name(s)
Treatment with Combo
Intervention Description
Treatment with Combo
Intervention Type
Other
Intervention Name(s)
Treatment with placebo
Intervention Description
Treatment with placebo
Primary Outcome Measure Information:
Title
NASH reduction: the main expected benefit is resolution of NASH, and no worsening of fibrosis
Description
Evolution of the SAF score and CAP elastometry, a composite histological score taking into account the improvement of Steatosis, histological activity and liver fibrosis
Time Frame
At 6 months
Secondary Outcome Measure Information:
Title
Initial correlation of NASH parameters (FIB4, NAFLD and liver stiffness) and symbiosis parameters (stool analysis by Shallow Shotgun, biological data specific to symbiosis).
Time Frame
At the screening
Title
Follow up of transaminase levels
Time Frame
At 6 months
Title
Reduction of hepatic steatosis measured by CAP elastometry and Hepatic MRI
Time Frame
At 6 months
Other Pre-specified Outcome Measures:
Title
Follow up of Biological Scores (FIB4, NAFLD) throughout the study
Time Frame
At 6 months
Title
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.
Time Frame
At 6 months
Title
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.
Time Frame
At 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Isabelle ROSA, Ph D
Phone
01 57 02 27 30
Email
isabelle.rosa@chicreteil.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Luc LEITZ
Email
luc.heitz@mativa-tech.com
Facility Information:
Facility Name
Centre Hospitalier Intercommunal Créteil
City
Créteil
ZIP/Postal Code
94010
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Isabelle ROSA, MD
Email
isabelle.rosa@chicreteil.fr
Facility Name
Centre Hospitalier Intercommunal de Villeneuve St Georges
City
Villeneuve St Georges
ZIP/Postal Code
94190
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Armand GARIOUD, PhD
Email
armand.garioud@chiv.fr

12. IPD Sharing Statement

Plan to Share IPD
No

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