Clinical trial NCT04781933: Interest in "Combo" (a Combination of Dietary Supplements Including Probiotics) in NASH Improvement
Official title: Interest in "Combo" (a Combination of Dietary Supplements Including Probiotics) in NASH Improvement
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: NASH - Nonalcoholic Steatohepatitis
Keywords: Combo
liver stiffness
gut microbiota
dietary supplements
Lead sponsor: Mativa-Tech SA
Sponsor class: INDUSTRY
First posted: 2021-03-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: NASH reduction: the main expected benefit is resolution of NASH, and no worsening of fibrosis
timeFrame: At 6 months
Secondary outcomes:
measure: Initial correlation of NASH parameters (FIB4, NAFLD and liver stiffness) and symbiosis parameters (stool analysis by Shallow Shotgun, biological data specific to symbiosis).
timeFrame: At the screening
measure: Follow up of transaminase levels
timeFrame: At 6 months
measure: Reduction of hepatic steatosis measured by CAP elastometry and Hepatic MRI
timeFrame: At 6 months
Other outcomes:
measure: Follow up of Biological Scores (FIB4, NAFLD) throughout the study
timeFrame: At 6 months
measure: 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.
timeFrame: At 6 months
measure: 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.
timeFrame: At 6 months
Locations:
city: Créteil
country: France
facility: Centre Hospitalier Intercommunal Créteil
city: Villeneuve St Georges
country: France
facility: Centre Hospitalier Intercommunal de Villeneuve St Georges
Study officials:
References: