NCT04671186

Role of Probiotics in Treatment of Pediatric NAFLD Patients by Assessing With Fibroscan

Role of Probiotics in Treatment of Pediatric Nonalcoholic Fatty Liver Disease (NAFLD) Patients by Assessing With Fibroscan

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Northwell Health · Academic / Other
• Sex: All
• Age: 5 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this study is to evaluate the role of probiotics in the treatment of pediatric NAFLD by evaluating for steatosis and fibrosis with a Fibroscan machine. This will be done by performing a fibroscan during each visit and comparing patients' ALT at various intervals. This is an important study as current pediatric guidelines only recommend lifestyle modifications for the treatment of NAFLD and the use of ALT and sonogram to assess improvement as standard of care. Investigators hypothesized that treatment with a probiotic will demonstrate an improvement in NAFLD as assessed by a fibroscan of liver which is good for the monitoring of steatosis and fibrosis. Additionally, analysis of fecal microbiome results may offer insight into targeted therapy in the future.

Detailed description

The goal/objective of this study is to evaluate the role of probiotics in the treatment of NAFLD by assessing with fibroscan in both newly diagnosed and known pediatric patients with NAFLD. This will be done by performing a fibroscan during each visit and comparing patient ALT and fecal microbiome at various intervals. The primary endpoint is to assess the effect of probiotic treatment in liver steatosis and fibrosis by assessing with fibroscan using CAP score and TE staging. The higher the CAP score (S1, S2, S3) so worse the steatosis. TE staging (F0-F4), higher the staging indicates worsening of fibrosis. Secondary endpoints include: * The rate of decline of ALT over 3 month time interval and through whole study starting at initial diagnosis. * The rate of decrease in hepatic steatosis and BMI This study will target pediatric patients with NAFLD. Participants will be new and previously diagnosed NAFLD patients between the ages of 5 years and 18 years. This is single center study. Investigators will enroll patients from The Division of Pediatric Gastroenterology, Liver Disease and Nutrition. Participants will be blindly randomized into one of two groups: probiotic or placebo. Investigators expect the study to run for 1 year from 09/15/2020 to 09/14/2021. Investigators will enroll patients over a 6 month period. After randomization into two separate groups (probiotic vs placebo), Investigators plan to collect data for the subsequent 6 months following enrollment.

Conditions

• Non-Alcoholic Fatty Liver Disease

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Culturelle (Lactobacillus rhamnosus strain GG)	Culturelle probiotics are typically sold over the counter as dietary supplements Probiotics group will take 1 capsule of probiotics orally once daily
OTHER	Placebo	Placebo group will take 1 capsule of placebo orally once daily

Timeline

• Start date: 2020-09-07
• Primary completion: 2021-09-06
• Completion: 2023-03-01
• First posted: 2020-12-17
• Last updated: 2023-04-14

Locations

1 site across 1 country: United States