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Probiotic

Probiotic group for Non-alcoholic Fatty Liver Disease

N/A
Waitlist Available
Led By Shari Sheflin-Findling
Research Sponsored by Northwell Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* 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
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one year

Summary

This trial is testing if probiotics can help children with fatty liver disease by improving their liver health. The study will use a special scan to check liver fat and scarring and track changes. Researchers hope that probiotics will show better results. Probiotics have been studied for their potential benefits in improving liver health, reducing liver inflammation, and improving metabolic parameters in patients with non-alcoholic fatty liver disease (NAFLD).

Eligible Conditions
  • Non-alcoholic Fatty Liver Disease (NAFLD)

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one year
This trial's timeline: 3 weeks for screening, Varies for treatment, and one year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
The role of probiotics in the treatment of pediatric NAFLD by evaluating for fibrosis with a Fibroscan machine.
The role of probiotics in the treatment of pediatric NAFLD by evaluating for steatosis with a Fibroscan machine.
Secondary study objectives
Change in fecal microbiome
Decrease in BMI
Rate of decline in ALT.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Probiotic groupExperimental Treatment1 Intervention
Probiotic group will receive Lactobacillus rhamnosus strain GG one capsule oral daily (10 billion CFU/day) throughout the study
Group II: Placebo GroupPlacebo Group1 Intervention
Placebo group is to receive placebo oral capsule daily throughout the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Culturelle (Lactobacillus rhamnosus strain GG)
2020
N/A
~50

Find a Location

Who is running the clinical trial?

Northwell HealthLead Sponsor
474 Previous Clinical Trials
469,113 Total Patients Enrolled
2 Trials studying Non-alcoholic Fatty Liver Disease
6 Patients Enrolled for Non-alcoholic Fatty Liver Disease
Shari Sheflin-FindlingPrincipal InvestigatorCohen Children's Medical Center
~9 spots leftby Nov 2025
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