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

Northwell Health

Status: Completed

Conditions: Non-Alcoholic Fatty Liver Disease

Treatments: Other: Placebo; Dietary Supplement: Culturelle (Lactobacillus rhamnosus strain GG)

Study type: Interventional

Funder types: Other

Identifiers

NCT04671186

20-0198

Details and patient eligibility

About

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.

Full 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.

Enrollment: 47 patients

Sex: All

Ages: 5 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

• 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)>

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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47 participants in 2 patient groups, including a placebo group

Probiotic group

Experimental group

Description:

Probiotic group will receive Lactobacillus rhamnosus strain GG one capsule oral daily (10 billion CFU/day) throughout the study

Treatment:

Dietary Supplement: Culturelle (Lactobacillus rhamnosus strain GG)

Placebo Group

Placebo Comparator group

Description:

Placebo group is to receive placebo oral capsule daily throughout the study.

Treatment:

Other: Placebo