CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 47 enrolled
Drug / intervention
Culturelle (Lactobacillus rhamnosus strain GG) +1 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04671186
NCT04671186N/ACompleted

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

Northwell Health·interventional·Posted Dec 17, 2020·Updated Apr 14, 2023

In Brief

A clinical study evaluating Culturelle (Lactobacillus rhamnosus strain GG) and Placebo for Non-Alcoholic Fatty Liver Disease. Completed, enrolled 47 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedDec 17, 2020
Enrollment StartSep 7, 2020
Primary CompletionSep 6, 2021
Study CompletionMar 1, 2023
TodayJul 2, 2026
Enrollment to primary: 12 monthsPosted 5.5 years ago

Interventions

Culturelle (Lactobacillus rhamnosus strain GG)dietary

Culturelle probiotics are typically sold over the counter as dietary supplements Probiotics group will take 1 capsule of probiotics orally once daily

Placeboother

Placebo group will take 1 capsule of placebo orally once daily