The Effect of Probiotic VSL#3 and Lifestyle Intervention in Obese Children with Non-Alcoholic Fatty Liver Disease (NAFLD)

Phase 1

Completed

• Conditions: Obese children with Non alcoholic Fatty Liver Disease

• Registration Number: CTRI/2017/12/010997
• Lead Sponsor: Babe Ke Ayurvedic Hospital VPO Daudhar

Brief Summary

This is a randomized double blind placebo controlled trial to study the supplementation with probiotic VSL#3 for the treatment of fatty liver disease in obese children.This study is for 24 months from the begining (surveying & recruiting 18 months@ VSL#3 supplementation & placebo for 4 months. This study population for screening will obese children and 100 will be recruited for participating in the trial from schools of jagraon city ludhiana and daudhar Punjab. 50% children for VSL#3 and another 50 %children for Placebo(corn starch). lifestyle (Diet and aerobic excercise) will be modified for the both groups. 4 capsules that contain 450 billion bacteria will provide to less than 10 yrs child and 8 capsules that contain 900 billion bacteria for above 10 yrs child dosage is defined by Pediatrician for 4 months intervention. The primary outcome is the evaluation of VSL#3 supplementation for treating fatty liver disease in obese children( reducing fatty liver grades). The secondary outcomes will be the effect of VSL#3 for controlling the biochemical parameters LFT lipid profile etc and leptin and ghrelin hormones.Anthropometric measurements also will be assessed before and after intervention.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-01
• Study Completion: 2019-07-01
• Last Update Posted: 2019-11-19

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Obese children in age group of 5-18 years old with NAFLD (BMI) ≥95th or 85th to 94th percentile with risk factors.

Exclusion Criteria

Presence of liver disease due to hypothyroidism, wilson disease, viral hepatitis, cystic fibrosis, celiac disease, autoimmune hepatitis, drugs induced steatosis and gastrointestinal abnormalities.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome is the evaluation of beneficial effect of probiotic VSl#3 for the treatment of fatty liver disease in obese children	4 months intervention

Secondary Outcome Measures

Name	Time	Method
Assessment of Probiotic VSL#3 for controlling the biochemical parameters LFT Lipid profile etc Hunger hormone leptin ghrelin	4 months intervention

Trial Locations

Locations (1)

ludhiana, Punjab; 🇮🇳 Ludhiana, PUNJAB, India

ludhiana, Punjab

🇮🇳Ludhiana, PUNJAB, India

Pooja Goyal

Principal investigator

9872033173

pooja_goyal9@yahoo.com