Status:
COMPLETED
The Effects of Synbiotics Supplement on Biochemical Factors and Hepatic Fibrosis in Patients With Nonalcoholic Steatohepatitis
Lead Sponsor:
National Nutrition and Food Technology Institute
Conditions:
Non Alcoholic Steatohepatitis
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
PHASE3
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT01791959
Start Date
March 1 2012
End Date
January 1 2013
Last Update
February 15 2013
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