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The effect of probiotics on changes in liver enzymes, lipid factors and ultrasound evidence in children and adolescents aged 10 to 18 years with non-alcoholic fatty liver

Phase 3
Conditions
on-alcoholic fatty liver disease.
Non-alcoholic fatty liver disease
DB92
Registration Number
IRCT20220314054279N1
Lead Sponsor
Kashan University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
60
Inclusion Criteria

Children and adolescents 10 to 18 years of age with non-alcoholic fatty liver disease confirmed by ultrasound and ALT more than 1.5 to 5 times normal

Exclusion Criteria

Patients with alcoholic steatohepatitis
Patients with systemic diseases (such as diabetes), inflammatory diseases, autoimmune diseases of the liver
Positive serology of viral hepatitis
Positive AMA ANA
Positive Ceruloplasmin
Children with hypothyroidism
Taking nutritional supplements
Other secondary causes of fatty liver
Patients with any medication that affects the liver
Liver enzyme levels are more than 6 times normal

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
iver enzymes (ALT,AST). Timepoint: At the beginning of the study, 8 weeks after taking the drug. Method of measurement: blood test.;Lipid factors (cholesterol, LDL, HDL). Timepoint: At the beginning of the study, 8 weeks after taking the drug. Method of measurement: blood test.;Fatty liver grade. Timepoint: At the beginning of the study, 8 weeks after taking the drug. Method of measurement: Sonography.
Secondary Outcome Measures
NameTimeMethod
Body mass index. Timepoint: At the beginning of the study, 8 weeks after taking the drug. Method of measurement: Meters to measure height and scales to measure weight.;Fasting blood sugar. Timepoint: At the beginning of the study, 8 weeks after taking the drug. Method of measurement: Blood test.
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