Non Alcoholic Steatohepatitis Clinical Trial
Introduction: Currently, Nonalcoholic Fatty Liver Disease (NAFLD) is the most common liver
disease in the world. The only approved treatment for it is lifestyle modification and
weight loss; however, there is no evidence for patients with normal or low body mass index
(BMI).
The aim of this study is to evaluate the efficacy of symbiotic supplementation in NAFLD
patients with normal or low BMI.
Methods and analysis: In this randomized, double-blind, placebo-controlled clinical trial
protocol, 21 cases and 21 controls will be individually matched based on age and sex. This
42 patients with NAFLD will be supplemented twice daily for 28 wk with either a synbiotic or
a placebo capsule. Both groups will be advised to follow an energy balanced diet and
physical activity recommendations.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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