Non-alcoholic Fatty Liver Disease Clinical Trial
Official title:
The Effect of Helicobacter Pylori Eradication on Liver Function Tests in Subjects With Non-alcoholic Fatty Liver Disease
The aim of study was to evaluate the effect of helicobacter pylori eradication on liver function tests, lipid profile, homeostasis model assessment-IR (HOMA-IR) index, and anthropometric measurements (body mass index and waist circumference)in subjects with non-alcoholic fatty liver disease.
Helicobacter pylori (HP) antigens have been found in the liver of individuals with benign
and malignant liver diseases. The role of HP in the pathogenesis of non-alcoholic fatty
liver disease (NAFLD) is controversial.
This randomized double blind clinical trial was performed in dyspeptic patients with
positive antibody to HP and the evidence of fatty liver in ultrasonography. After excluding
other causes, participants with persistent elevated serum aminotransferase levels were
presumed to have NAFLD. Those with NAFLD liver fat score greater than (-0.64) and positive
urea breath test (UBT) were enrolled. They were randomly assigned to lifestyle modification
alone or lifestyle modification plus HP eradication groups. Quadruple therapy (omeprazole,
amoxicillin, bismuth subcitrate, and clarithromycin) for HP eradication was performed in two
weeks. HP eradication was documented by UBT. Fasting serum glucose, alanine
aminotransferase, aspartate aminotransferase, alkaline phosphatase, triglyceride,
cholesterol, high and low-density lipoprotein, HOMA-IR, and anthropometric measurements
(body mass index and waist circumference) were checked at baseline, eight weeks, and twelve
weeks from the beginning of study.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
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