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

Non-Alcoholic Fatty Liver Disease Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Non-Alcoholic Fatty Liver Disease

• NCT number: NCT04671186
• Study type: Interventional
• Source: Northwell Health
• Status: Completed
• Phase: N/A
• Start date: September 7, 2020
• Completion date: March 1, 2023