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

Not Applicable

Recruiting

• Conditions: NASH - Nonalcoholic Steatohepatitis
• Interventions: Other: Treatment with placebo; Dietary Supplement: Treatment with Combo

• Registration Number: NCT04781933
• Lead Sponsor: Mativa-Tech SA

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

Study Timeline

• Study First Submitted: 2021-02-17
• Study First Submitted QC: 2021-03-01
• Study First Posted: 2021-03-04
• Study Start: 2023-01-01
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-06
• Last Update Posted: 2023-11-07
• Primary Completion: 2024-01-01
• Study Completion: 2025-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment with Placebo	Treatment with placebo	3 placebos will be given
Treatment with Combo	Treatment with Combo	3 dietary supplements will be given

Primary Outcome Measures

Name	Time	Method
NASH reduction: the main expected benefit is resolution of NASH, and no worsening of fibrosis	At 6 months	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

Name	Time	Method
Follow up of transaminase levels	At 6 months
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
Reduction of hepatic steatosis measured by CAP elastometry and Hepatic MRI	At 6 months

Trial Locations

Locations (2)

Centre Hospitalier Intercommunal Créteil; 🇫🇷 Créteil, France

Centre Hospitalier Intercommunal de Villeneuve St Georges; 🇫🇷 Villeneuve St Georges, France