NCT04781933

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Mativa-Tech SA · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Conditions

• NASH - Nonalcoholic Steatohepatitis

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Treatment with Combo	Treatment with Combo
OTHER	Treatment with placebo	Treatment with placebo

Timeline

• Start date: 2023-01-01
• Primary completion: 2024-01-01
• Completion: 2025-01-01
• First posted: 2021-03-04
• Last updated: 2023-11-07

Locations

2 sites across 1 country: France