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

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ClinicalTrials.gov Identifier: NCT04671186
Recruitment Status : Recruiting
First Posted : December 17, 2020
Last Update Posted : December 17, 2020
Sponsor:
Information provided by (Responsible Party):
Northwell Health

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Non-Alcoholic Fatty Liver Disease Dietary Supplement: Culturelle (Lactobacillus rhamnosus strain GG) Other: Placebo Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be blindly randomized at Visit 1 into one of two groups (probiotic or placebo). Probiotic group will receive Lactobacillus rhamnosus strain GG one capsule oral daily (10 billion CFU/day) and the other group receive placebo oral capsule daily throughout the study. All participants in either group will undergo: Life style modification as per NASPGHAN NAFLD guidelines. Fibroscan assessing CAP and TE score once every 3 month until the end of study. Monitoring ALT every 3 months until end of study as per standard of care guidelines.Collection of stool sample to be sent for microbiome analysis at the time of diagnosis, 3 months and 6 months (end of the study). Secondary variables collected, Age, Gender, Race, BMI, Fibroscan probe.
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Participants will be blindly randomized at baseline (Visit 1) into one of two groups: probiotic or placebo. Investigators are to be blinded as well
Primary Purpose: Treatment
Official Title: Role of Probiotics in Treatment of Pediatric Nonalcoholic Fatty Liver Disease (NAFLD) Patients by Assessing With Fibroscan
Actual Study Start Date : September 7, 2020
Estimated Primary Completion Date : September 6, 2021
Estimated Study Completion Date : September 6, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. Change in fecal microbiome [ Time Frame: One year ]
    Compare changes in stool microbiome

  3. Decrease in BMI [ Time Frame: One year ]
    The rate of change in hepatic steatosis with change in BMI


Eligibility Criteria
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Ages Eligible for Study:   5 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)>
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04671186


Contacts
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Contact: Kanya Ahuja, MBBS 516-4723650 kahuja3@northwell.edu
Contact: Shari Sheflin-Findling, DO 516-4723650 SSheflin@northwell.edu

Locations
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United States, New York
Cohen Children's Medical Center Recruiting
New Hyde Park, New York, United States, 11042
Contact: Kanya Ahuja, MBBS    516-472-3650    kahuja3@northwell.edu   
Contact: Shari Sheflin-Findling, DO    516-4723650    SSheflin@northwell.edu   
Sponsors and Collaborators
Northwell Health
Investigators
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Principal Investigator: Shari Sheflin-Findling Cohen Children's Medical Center
  Study Documents (Full-Text)

Documents provided by Northwell Health:
Study Protocol and Statistical Analysis Plan  [PDF] April 21, 2020
Informed Consent Form  [PDF] April 21, 2020

More Information
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Publications:
Comparison of Controlled Attenuation Parameter and Liver Biopsy to Assess Hepatic Steatosis in Pediatric PatientsAuthor links open overlay panel NiravK.DesaiMD1,SarahHarneyBA1,RoshanRazaMD1,AlyaaAlIbraheemiMD2, NickShillingfordMD2, Paul D.MitchellMS3, Maureen M.JonasMD1
Effects of Clinically Significant Weight Loss with Exercise Training on Insulin Resistance and Cardiometabolic Adaptations. Damon L. Swift, Ph.D.,1,2 Neil M. Johannsen, Ph.D.,3 Carl J. Lavie, M.D.,4 Conrad P. Earnest, Ph.D.,5 Steven N. Blair, P.E.D.,6 and Timothy S. Church, M.D., Ph.D.7 2005;102(31):11070-11075. doi:10.1073/pnas.0504978102

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Responsible Party: Northwell Health
ClinicalTrials.gov Identifier: NCT04671186    
Other Study ID Numbers: 20-0198
First Posted: December 17, 2020    Key Record Dates
Last Update Posted: December 17, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases