The Effects of Synbiotics Supplement on Biochemical Factors and Hepatic Fibrosis in Patients With Nonalcoholic Steatohepatitis

Phase 2

Completed

• Conditions: Non Alcoholic Steatohepatitis
• Interventions: Dietary Supplement: synbiotic; Other: placebo

• Registration Number: NCT01791959
• Lead Sponsor: National Nutrition and Food Technology Institute

Brief Summary

To study the effects of synbiotics supplement on lipid profile, liver enzymes, inflammatory factors and hepatic fibrosis in patients with Nonalcoholic Steatohepatitis (NASH), 50 patients who referred to Gastrointestinal (GI) clinic with steatosis grade 1 or more will be randomly allocated to receive 2 protexin capsules or placebos for 7 months; both groups will be advised to adherence our diet and exercise program too. At the first and the end of the intervention, lipid profiles, liver enzymes, some inflammatory cytokines, and liver fibrosis will be assessed and compared between groups.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Primary Completion: 2012-10
• Study Completion: 2013-01
• Status Verified: 2013-02
• Study First Submitted: 2013-02-05
• Study First Submitted QC: 2013-02-12
• Last Update Submitted: 2013-02-12
• Study First Posted: 2013-02-15
• Last Update Posted: 2013-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

• Age of 18 to 70 years
• Body Mass Index (BMI) between 25-40
• Serum alaninaminotransferase more than 1.5 fold of upper limit of normal range
• Sonographic findings compatible with hepatic steatosis (degree 2 or more)

Exclusion Criteria

• Diabetes
• Taking any kind of antibiotics two weeks before recruitment
• History of alcohol consumption
• pregnancy or lactation
• Professional athletes
• Other liver disease (viral/etc)
• Use of drugs such as calcium channel blockers, high dose synthetic estrogens, methotrexate , amiodarone, steroids, chloroquine, immunosuppressive drugs, lipid-lowering agents, metformin and vitamin E
• A history of Hypertension, Cardiovascular disease, Pulmonary disease, Renal disease & Celiac disease; Cirrhosis
• History of Upper GI surgery / Prior surgical procedures such as jejunoileal or jejunocolic bypass, gastroplasty
• Following program to lose weight in recent 3 mo
• A history of hypothyroidism or Cushing's syndrome

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Synbiotic	synbiotic	2 synbiotic capsules for 28 weeks
maltodexterin	placebo	two capsules per day for 28 weeks

Primary Outcome Measures

Name	Time	Method
Alaninaminotransferase (ALT)	28 weeks
Liver fibrosis	28 weeks

Secondary Outcome Measures

Name	Time	Method
Body Mass Index (BMI)	28 weeks