Effect of Probiotics in the management of fatty liver disease in obese children.

Phase 4

Recruiting

• Conditions: on alcoholic fatty liver disease and Non alcoholic steato hepatitis in Obese children.

• Registration Number: SLCTR/2016/021
• Lead Sponsor: Department of Paediatrics, Faculty of Medicine, University of Colombo

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 20 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

1. Age limit: 5yrs - 15yrs
2. Sex: males and females
3. Body Mass Index +2 standard deviations (SD) above the median BMI for age reference (using WHO, 2007 standards)
4. Diagnosis of NAFLD/ NASH with AST/ ALT ratio less than 1 and ultra sound scan evidence of NAFLD/ NASH.

Exclusion Criteria

1. Children with acute infection,
2. Long term medications (> 3 months continuously)
3. Long standing illness on long term medication
4. Children with inherited conditions.
5. Administration of antibiotics in the 2 month period before enrollment

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Reduction in Alanine transaminase (ALT), Aspartate aminotransferase (AST) <br>2. Reversal of AST:ALT ratio<br>3. Transient elastographic (fibroscan) assessment of stiffness of the liver and quantification of steatosis<br>4. Ultrasound grade of NAFLD/ NASH.<br> [At baseline (just before commencement of therapy) and 6 months after completion of the course of therapy.]<br>

Secondary Outcome Measures

Name	Time	Method
1. Reduction in GT (gamma glutamyl transferase), <br>2. Improvement of the lipid profile <br>3. Improvement in glucose homeostasis, metabolic syndrome, fat mass of body and anterior abdominal wall subcutaneous fat <br>4. Improvement of anthropometric parameters.<br> [Outcomes 1-3 will be measured at baseline and at 6 months following commencement of the intervention<br><br>Outcome 4 will be measured at baseline and then monthly for a total of 6 months<br>]<br>