The effects of synbiotics supplement on lipid profile, liver enzymes, inflammatory factors and hepatic fibrosis in patients with Nonalcoholic Steatohepatitis
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.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201012084010N4
Registration date:2012-11-30, 1391/09/10
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-11-30, 1391/09/10
Registrant information
Name
Azita Hekmatdoost
Name of organization / entity
Shahid Beheshti University of Medical Sciences, National Institute of Nutrition Research
Country
Iran (Islamic Republic of)
Phone
+98 21 2293 0824
Email address
hekmat@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
National Nutrition and Food Technology Research Institute (NNFTRI) and Digestive Disease Research Institute (DDRI)
Expected recruitment start date
2012-02-22, 1390/12/03
Expected recruitment end date
2012-09-25, 1391/07/04
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of synbiotics supplement on lipid profile, liver enzymes, inflammatory factors and hepatic fibrosis in patients with Nonalcoholic Steatohepatitis
Public title
The effects of healthy bacteria supplementation on lipid profile, liver enzymes, inflammatory factors and hepatic fibrosis in patients with Nonalcoholic Steatohepatitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 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.
Age
From 18 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
National Nutrition and Food Technology Research Institute (NNFTRI)