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

NCT04671186 | Completed DMC

• 1 other identifier: 20-0198
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-Alcoholic Fatty Liver Disease

Outcome Measures

Primary Outcomes (2)

• The role of probiotics in the treatment of pediatric NAFLD by evaluating for steatosis with a Fibroscan machine.

  The primary endpoint/outcome assesses the effect of probiotic treatment in liver steatosis by assessing with fibroscan using CAP score.

  One year

• The role of probiotics in the treatment of pediatric NAFLD by evaluating for fibrosis with a Fibroscan machine.

  The primary endpoint/outcome assesses the effect of probiotic treatment in liver fibrosis by assessing with fibroscan using TE staging.

  One year

Secondary Outcomes (3)

• Rate of decline in ALT.

  One year

• Change in fecal microbiome

  One year

• Decrease in BMI

  One year

Study Arms (2)

Probiotic group

EXPERIMENTAL

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)

Placebo Group

PLACEBO COMPARATOR

Placebo group is to receive placebo oral capsule daily throughout the study.

Other: Placebo

Interventions

Culturelle (Lactobacillus rhamnosus strain GG) DIETARY_SUPPLEMENT

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

Probiotic group

Placebo OTHER

Placebo group will take 1 capsule of placebo orally once daily

Placebo Group

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)\>

Sponsors & Collaborators

• Northwell Health: lead

Study Sites (1)

Cohen Children's Medical Center

New Hyde Park, New York, 11042, United States

Location

Related Publications (21)

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• Alisi A, Manco M, Vania A, Nobili V. Pediatric nonalcoholic fatty liver disease in 2009. J Pediatr. 2009 Oct;155(4):469-74. doi: 10.1016/j.jpeds.2009.06.014. No abstract available.

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• Paolella G, Mandato C, Pierri L, Poeta M, Di Stasi M, Vajro P. Gut-liver axis and probiotics: their role in non-alcoholic fatty liver disease. World J Gastroenterol. 2014 Nov 14;20(42):15518-31. doi: 10.3748/wjg.v20.i42.15518.

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• Vos MB, Abrams SH, Barlow SE, Caprio S, Daniels SR, Kohli R, Mouzaki M, Sathya P, Schwimmer JB, Sundaram SS, Xanthakos SA. NASPGHAN Clinical Practice Guideline for the Diagnosis and Treatment of Nonalcoholic Fatty Liver Disease in Children: Recommendations from the Expert Committee on NAFLD (ECON) and the North American Society of Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN). J Pediatr Gastroenterol Nutr. 2017 Feb;64(2):319-334. doi: 10.1097/MPG.0000000000001482.

  PMID: 28107283 BACKGROUND

• 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

  BACKGROUND

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• Draijer L, Benninga M, Koot B. Pediatric NAFLD: an overview and recent developments in diagnostics and treatment. Expert Rev Gastroenterol Hepatol. 2019 May;13(5):447-461. doi: 10.1080/17474124.2019.1595589. Epub 2019 Apr 4.

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• Vajro P, Mandato C, Licenziati MR, Franzese A, Vitale DF, Lenta S, Caropreso M, Vallone G, Meli R. Effects of Lactobacillus rhamnosus strain GG in pediatric obesity-related liver disease. J Pediatr Gastroenterol Nutr. 2011 Jun;52(6):740-3. doi: 10.1097/MPG.0b013e31821f9b85.

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MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Officials

• Shari Sheflin-Findling

  Cohen Children's Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Participants will be blindly randomized at baseline (Visit 1) into one of two groups: probiotic or placebo. Investigators are to be blinded as well
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 1, 2020
• First Posted: December 17, 2020
• Study Start: September 7, 2020
• Primary Completion: September 6, 2021
• Study Completion: March 1, 2023
• Last Updated: April 14, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)