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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-01

Study Completion Date

2025-01-01

Brief Summary

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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.

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Detailed Description

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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

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NASH - Nonalcoholic Steatohepatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Treatment with Combo

3 dietary supplements will be given

Group Type ACTIVE_COMPARATOR

Treatment with Combo

Intervention Type DIETARY_SUPPLEMENT

Treatment with Combo

Treatment with Placebo

3 placebos will be given

Group Type PLACEBO_COMPARATOR

Treatment with placebo

Intervention Type OTHER

Treatment with placebo

Interventions

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Treatment with Combo

Intervention Type DIETARY_SUPPLEMENT

Treatment with placebo

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No