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

Mativa-Tech

Status: Enrolling

Conditions: NASH - Nonalcoholic Steatohepatitis

Treatments: Other: Treatment with placebo; Dietary Supplement: Treatment with Combo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04781933

ICAN

Details and patient eligibility

About

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.

Full 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

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

Treatment with Combo

Active Comparator group

Description:

3 dietary supplements will be given

Treatment:

Dietary Supplement: Treatment with Combo

Treatment with Placebo

Placebo Comparator group

Description:

3 placebos will be given

Treatment:

Other: Treatment with placebo