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

NCT01791959 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2013-02-15

No results posted yet for this study

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

DIETARY_SUPPLEMENT

synbiotic

2 symbiotics capsules per day for 28 weeks

OTHER

placebo

2 Maltodexterin capsules as a placebo per day for 28 weeks

Sponsors & Collaborators

  • National Nutrition and Food Technology Institute

    lead OTHER

Principal Investigators

  • Azita Hekmatdoost, MD, PhD · National Nutrition and Food Technology Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2012-10-31
Completion
2013-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01791959 on ClinicalTrials.gov