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

National Nutrition and Food Technology Institute0 sites54 target enrollmentMarch 2012

ConditionsNon Alcoholic Steatohepatitis

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Non Alcoholic Steatohepatitis
Sponsor: National Nutrition and Food Technology Institute
Enrollment: 54
Primary Endpoint: Alaninaminotransferase (ALT)
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 2012

End Date

January 2013

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

National Nutrition and Food Technology Institute

Responsible Party

Principal Investigator

Dr Azita Hekmatdoost

Principal Investigator

National Nutrition and Food Technology Institute

Eligibility Criteria

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

•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