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

Sponsor

National Nutrition and Food Technology Institute (Other)

Overall Status

Completed

CT.gov ID

NCT01791959

Collaborator

(none)

Enrollment

Arms

10.1

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Non Alcoholic Steatohepatitis	Dietary Supplement: synbiotic Other: placebo	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

54 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Mar 1, 2012

Actual Primary Completion Date :

Oct 1, 2012

Actual Study Completion Date :

Jan 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Synbiotic 2 synbiotic capsules for 28 weeks	Dietary Supplement: synbiotic 2 symbiotics capsules per day for 28 weeks
Placebo Comparator: maltodexterin two capsules per day for 28 weeks	Other: placebo 2 Maltodexterin capsules as a placebo per day for 28 weeks

Arm

Intervention/Treatment

Active Comparator: Synbiotic

2 synbiotic capsules for 28 weeks

Dietary Supplement: synbiotic

2 symbiotics capsules per day for 28 weeks

Placebo Comparator: maltodexterin

two capsules per day for 28 weeks

Other: placebo

2 Maltodexterin capsules as a placebo per day for 28 weeks

Outcome Measures

Primary Outcome Measures

Alaninaminotransferase (ALT) [28 weeks]
Liver fibrosis [28 weeks]

Secondary Outcome Measures

Body Mass Index (BMI) [28 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

National Nutrition and Food Technology Institute

Investigators

Principal Investigator: Azita Hekmatdoost, MD, PhD, National Nutrition and Food Technology Research Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dr Azita Hekmatdoost, Principal Investigator, National Nutrition and Food Technology Institute

ClinicalTrials.gov Identifier:

NCT01791959

Other Study ID Numbers:

046466

First Posted:

Feb 15, 2013

Last Update Posted:

Feb 15, 2013

Last Verified:

Feb 1, 2013

Additional relevant MeSH terms:

Fatty Liver

Non-alcoholic Fatty Liver Disease

Study Results

No Results Posted as of Feb 15, 2013