Role of Probiotics in Treatment of Pediatric NAFLD Patients by Assessing With Fibroscan
Condition: Non-Alcoholic Fatty Liver Disease
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional

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.
    

Intervention name(s): Culturelle (Lactobacillus rhamnosus strain GG); Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Culturelle probiotics are typically sold over the counter as dietary supplements Probiotics group will take 1 capsule of probiotics orally once daily; Placebo group will take 1 capsule of placebo orally once daily
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention 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)
Primary purpose: Treatment