NCT01791959

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

The Effects of Synbiotics Supplement on Lipid Profile, Liver Enzymes, Inflammatory Factors and Hepatic Fibrosis in Patients With Nonalcoholic Steatohepatitis

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: National Nutrition and Food Technology Institute · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non Alcoholic Steatohepatitis

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	synbiotic	2 symbiotics capsules per day for 28 weeks
OTHER	placebo	2 Maltodexterin capsules as a placebo per day for 28 weeks

Timeline

• Start date: 2012-03-01
• Primary completion: 2012-10-01
• Completion: 2013-01-01
• First posted: 2013-02-15
• Last updated: 2013-02-15