The effects of healthy bacteria supplementation on lipid profile, liver enzymes, inflammatory factors and hepatic fibrosis in patients with Nonalcoholic Steatohepatitis
- Conditions
- onalcoholic steatohepatitis (NASH).Nonalcoholic steatohepatitis (NASH)
- Registration Number
- IRCT201012084010N4
- Lead Sponsor
- ational Nutrition and Food Technology Research Institute (NNFTRI)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 50
Age of 18 years and older; BMI between 25-40; Abnormal serum transferase (ALT & AST more than 1.5 fold of normal range); Sonographic findings compatible with hepatic steatosis (degree 2 or more). Exclusion criteria: Diabetes; Using antibiotic 2 weeks before recruitment to the study; A history of alcohol consumption; Pregnancy & Breast feeding, Professional athletes; 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; Medications causing NAS; 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.
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ALT, AST, GGT. Timepoint: at the beginning and at the last. Method of measurement: Biochemistry.;Hs-CRP, TNF-a. Timepoint: at the beginning and at the last. Method of measurement: ELISA & Nephlometer.;Liver fibrosis. Timepoint: at the beginning and at the last. Method of measurement: Fibroscan.;FBS. Timepoint: at the beginning and at the last. Method of measurement: Biochemistry.;Cholestrol, TG, LDL-c, HDL-c. Timepoint: at the beginning and at the last. Method of measurement: Biochemistry.
- Secondary Outcome Measures
Name Time Method Weight and BMI. Timepoint: at weeks: 0, 14, 28. Method of measurement: Weight will be measured by Secca scale , BMI by formula.;Waist circumference, hip circumfereance. Timepoint: at weeks: 0, 14, 28. Method of measurement: non stretch meter.;Insulin. Timepoint: at weeks: 0, 14, 28. Method of measurement: ELISA.;Insulin resistance. Timepoint: at weeks: 0, 28. Method of measurement: formula.