Role of Probiotics in Treatment of Pediatric NAFLD Patients by Assessing With Fibroscan
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Non Alcoholic Fatty Liver Disease
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Participants will be blindly randomized at Visit 1 into one of two groups (probiotic or placebo). Probiotic group will receive Lactobacillus rhamnosus strain GG one capsule oral daily (10 billion CFU/day) and the other group receive placebo oral capsule daily throughout the study. All participants in either group will undergo: Life style modification as per NASPGHAN NAFLD guidelines. Fibroscan assessing CAP and TE score once every 3 month until the end of study. Monitoring ALT every 3 months until end of study as per standard of care guidelines.Collection of stool sample to be sent for microbiome analysis at the time of diagnosis, 3 months and 6 months (end of the study). Secondary variables collected, Age, Gender, Race, BMI, Fibroscan probe.Masking: Triple (Participant, Care Provider, Investigator)Masking Description: Participants will be blindly randomized at baseline (Visit 1) into one of two groups: probiotic or placebo. Investigators are to be blinded as wellPrimary Purpose: Treatment
Participation Requirements
- Age
- Between 5 years and 18 years
- Gender
- Both males and females
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 a...
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.
Tracking Information
- NCT #
- NCT04671186
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Shari Sheflin-Findling Cohen Children's Medical Center
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