Role of Probiotics in Treatment of Pediatric NAFLD Patients by Assessing With Fibroscan
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Interventions
- Other: PlaceboDietary Supplement: Culturelle (Lactobacillus rhamnosus strain GG)
- Registration Number
- NCT04671186
- Lead Sponsor
- Northwell Health
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 47
- 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. Diagnosis must be made by elevated serum ALT (two times above the sex specific upper limit of normal) and a sonogram consistent with steatosis
-
Exclusion criteria for both groups
- Concomitant underlying liver disease such as but not limited to autoimmune hepatitis
- Concomitant infectious hepatitis
- Medication use of steroids, methotrexate, metformin, and therapeutic dose of Vit. E
- Recent antibiotic use in last 4 weeks
- Clinically significant weight loss (at least 5% reduction in weight from baseline level [18]) on follow up NAFLD patients who were on life style modification intervention
- Cirrhosis (Fibroscan score ≥14.0)>
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Group Placebo Placebo group is to receive placebo oral capsule daily throughout the study. Probiotic group Culturelle (Lactobacillus rhamnosus strain GG) Probiotic group will receive Lactobacillus rhamnosus strain GG one capsule oral daily (10 billion CFU/day) throughout the study
- Primary Outcome Measures
Name Time Method The role of probiotics in the treatment of pediatric NAFLD by evaluating for fibrosis with a Fibroscan machine. One year The primary endpoint/outcome assesses the effect of probiotic treatment in liver fibrosis by assessing with fibroscan using TE staging.
The role of probiotics in the treatment of pediatric NAFLD by evaluating for steatosis with a Fibroscan machine. One year The primary endpoint/outcome assesses the effect of probiotic treatment in liver steatosis by assessing with fibroscan using CAP score.
- Secondary Outcome Measures
Name Time Method Rate of decline in ALT. One year The rate of decline of ALT over 3 month time interval and through whole study starting at initial diagnosis.
Decrease in BMI One year The rate of change in hepatic steatosis with change in BMI
Change in fecal microbiome One year Compare changes in stool microbiome
Trial Locations
- Locations (1)
Cohen Children's Medical Center
🇺🇸New Hyde Park, New York, United States