NCT04781933

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2023

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 17, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 4, 2021

Completed
1.8 years until next milestone

Study Start

First participant enrolled

January 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

November 7, 2023

Status Verified

November 1, 2023

Enrollment Period

1 year

First QC Date

February 17, 2021

Last Update Submit

November 6, 2023

Conditions

NASH - Nonalcoholic Steatohepatitis

Keywords

Comboliver stiffnessgut microbiotadietary supplements

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 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 Outcomes (3)

  • 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

Study Arms (2)

Treatment with Combo

ACTIVE COMPARATOR

3 dietary supplements will be given

Dietary Supplement: Treatment with Combo

Treatment with Placebo

PLACEBO COMPARATOR

3 placebos will be given

Other: Treatment with placebo

Interventions

Treatment with ComboDIETARY_SUPPLEMENT

Treatment with Combo

Treatment with Combo
Treatment with placeboOTHER

Treatment with placebo

Treatment with Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • allergic to soya, aspirin, fish, E110 dye, Maltodextrin
  • poorly controlled diabetes (Glycated Hemoglobin \>8%)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centre Hospitalier Intercommunal Créteil

Créteil, 94010, France

RECRUITING

Centre Hospitalier Intercommunal de Villeneuve St Georges

Villeneuve-Saint-Georges, 94190, France

RECRUITING

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System Diseases

Central Study Contacts

Isabelle ROSA, Ph D

CONTACT

01 57 02 27 30isabelle.rosa@chicreteil.fr

Luc LEITZ

CONTACT

luc.heitz@mativa-tech.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pr

Study Record Dates

First Submitted

February 17, 2021

First Posted

March 4, 2021

Study Start

January 1, 2023

Primary Completion

January 1, 2024

Study Completion

January 1, 2025

Last Updated

November 7, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)