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

April 12, 2023 updated by: Northwell Health

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

47

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New Hyde Park, New York, United States, 11042
        • Cohen Children's Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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)>

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Probiotic group
Probiotic group will receive Lactobacillus rhamnosus strain GG one capsule oral daily (10 billion CFU/day) throughout the study
Dietary supplement: Culturelle (Lactobacillus rhamnosus strain GG)
Culturelle probiotics are typically sold over the counter as dietary supplements Probiotics group will take 1 capsule of probiotics orally once daily
Placebo Comparator: Placebo Group
Placebo group is to receive placebo oral capsule daily throughout the study.
Other: Placebo
Placebo group will take 1 capsule of placebo orally once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The role of probiotics in the treatment of pediatric NAFLD by evaluating for steatosis with a Fibroscan machine.
Time Frame: One year
The primary endpoint/outcome assesses the effect of probiotic treatment in liver steatosis by assessing with fibroscan using CAP score.
One year
The role of probiotics in the treatment of pediatric NAFLD by evaluating for fibrosis with a Fibroscan machine.
Time Frame: One year
The primary endpoint/outcome assesses the effect of probiotic treatment in liver fibrosis by assessing with fibroscan using TE staging.
One year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of decline in ALT.
Time Frame: One year
The rate of decline of ALT over 3 month time interval and through whole study starting at initial diagnosis.
One year
Change in fecal microbiome
Time Frame: One year
Compare changes in stool microbiome
One year
Decrease in BMI
Time Frame: One year
The rate of change in hepatic steatosis with change in BMI
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwell Health

Investigators

  • Principal Investigator: Shari Sheflin-Findling, Cohen Children's Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 7, 2020

Primary Completion (Actual)

September 6, 2021

Study Completion (Actual)

March 1, 2023

Study Registration Dates

First Submitted

September 1, 2020

First Submitted That Met QC Criteria

December 15, 2020

First Posted (Actual)

December 17, 2020

Study Record Updates

Last Update Posted (Actual)

April 14, 2023

Last Update Submitted That Met QC Criteria

April 12, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-0198

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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