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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
Awards & highlights

Study Summary

This trialwill examine if probiotics can help treat NAFLD in kids. Results from fibroscan and ALT tests will be compared to see if probiotics are effective.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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
458 Previous Clinical Trials
470,886 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this clinical examination include individuals aged 18 or over?

"To meet the requirements of this clinical trial, potential participants must be between 5 and 18 years old."

Answered by AI

Is it feasible to register for this medical experiment?

"In order to be part of this trial, the patient must have been diagnosed with fatty liver, non-alcoholic fatty liver disease (NAFLD) and be aged between 5 and 18. A total of 47 people will join this medical research endeavour."

Answered by AI

Are any more participants being recruited for this research at the present time?

"Clinicaltrials.gov records demonstrate that this research is not seeking new participants at present, despite having been initially published on September 7th 2020 and updated October 25th 2022. Nonetheless, there are currently 370 other studies actively enrolling patients around the world."

Answered by AI
Recent research and studies
NatureJournal
Inflammasome-mediated Dysbiosis Regulates Progression of NAFLD and Obesity
Henao-Mejia, Jorge, Eran Elinav, Chengcheng Jin, Liming Hao, Wajahat Z. Mehal, Till Strowig, Christoph A. Thaiss, et al.. 2012. “Inflammasome-mediated Dysbiosis Regulates Progression of NAFLD and Obesity”. Nature. Springer Science and Business Media LLC. doi:10.1038/nature10809.
GastroenterologyJournal
Nonalcoholic Steatohepatitis Is the Second Leading Etiology of Liver Disease Among Adults Awaiting Liver Transplantation in the United States
Wong, Robert J., Maria Aguilar, Ramsey Cheung, Ryan B. Perumpail, Stephen A. Harrison, Zobair M. Younossi, and Aijaz Ahmed. 2015. “Nonalcoholic Steatohepatitis Is the Second Leading Etiology of Liver Disease Among Adults Awaiting Liver Transplantation in the United States”. Gastroenterology. Elsevier BV. doi:10.1053/j.gastro.2014.11.039.
GutJournal
Intestinal Microbiota Determines Development of Non-alcoholic Fatty Liver Disease in Mice
Le Roy, Tiphaine, Marta Llopis, Patricia Lepage, Aurélia Bruneau, Sylvie Rabot, Claudia Bevilacqua, Patrice Martin, et al.. 2012. “Intestinal Microbiota Determines Development of Non-alcoholic Fatty Liver Disease in Mice”. Gut. BMJ. doi:10.1136/gutjnl-2012-303816.
Clinical Gastroenterology and HepatologyJournal
Evidence and Recommendations for Imaging Liver Fat in Children, Based on Systematic Review
Awai, Hannah I., Kimberly P. Newton, Claude B. Sirlin, Cynthia Behling, and Jeffrey B. Schwimmer. 2014. “Evidence and Recommendations for Imaging Liver Fat in Children, Based on Systematic Review”. Clinical Gastroenterology and Hepatology. Elsevier BV. doi:10.1016/j.cgh.2013.09.050.
~10 spots leftby Apr 2025
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