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

NCT04671186 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2023-04-14

No results posted yet for this study

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.

Conditions

  • Non-Alcoholic Fatty Liver Disease

Interventions

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

OTHER

Placebo

Placebo group will take 1 capsule of placebo orally once daily

Sponsors & Collaborators

  • Northwell Health

    lead OTHER

Principal Investigators

  • Shari Sheflin-Findling · Cohen Children's Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-07
Primary Completion
2021-09-06
Completion
2023-03-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04671186 on ClinicalTrials.gov