Status:
COMPLETED
Role of Probiotics in Treatment of Pediatric NAFLD Patients by Assessing With Fibroscan
Lead Sponsor:
Northwell Health
Conditions:
Non-Alcoholic Fatty Liver Disease
Eligibility:
All Genders
5-18 years
Phase:
NA
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 fi...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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)\>
Key Trial Info
Start Date :
September 7 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2023
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT04671186
Start Date
September 7 2020
End Date
March 1 2023
Last Update
April 14 2023
Active Locations (1)
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1
Cohen Children's Medical Center
New Hyde Park, New York, United States, 11042