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

Non Alcoholic Steatohepatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01791959
• Other study ID #: 046466
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: February 5, 2013
• Last updated: February 12, 2013
• Start date: March 2012
• Est. completion date: January 2013

Study information

• Verified date: February 2013
• Source: National Nutrition and Food Technology Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: IRAN: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: January 2013
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fatty Liver
• Non Alcoholic Steatohepatitis

Intervention

Dietary Supplement:
• synbiotic
2 symbiotics capsules per day for 28 weeks

Other:
• placebo
2 Maltodexterin capsules as a placebo per day for 28 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Nutrition and Food Technology Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Alaninaminotransferase (ALT)		28 weeks	Yes
Primary	Liver fibrosis		28 weeks	No
Secondary	Body Mass Index (BMI)		28 weeks	No