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

Completed · Not applicable · Has a placebo group

Conditions studied: Non-Alcoholic Fatty Liver Disease

In brief

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.

Key facts

Study ID

NCT04671186

Run by

Northwell Health

People needed

47

Starts

2020-09-07

Expected to finish

2023-03-01

Last updated by the study team

2023-04-14

Who can join

Age: 5 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

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…

• 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)>

Where it is running

• Cohen Children's Medical Center — New Hyde Park, New York, United States

Full record on ClinicalTrials.gov

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