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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

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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20220314054279N1
Enrollment
60
Registered
2022-03-17
Start date
2021-01-20
Completion date
Unknown
Last updated
2022-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-alcoholic fatty liver disease. Non-alcoholic fatty liver disease

Interventions

Intervention 1: Intervention group: Receive 500 mg Familact Capsules (Probiotic + Prebiotic) prepared from Zist Takhmir Company, once a day after meals for 8 weeks. Intervention 2: Control group: Rece

Sponsors

Kashan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
10 Years to 18 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Liver 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

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMaryam Naseri Taheri

Kashan University of Medical Sciences

naseritaherii@gmail.com+98 31 5531 9390

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: May 27, 2026