The Effect of Helicobacter Pylori Eradication on Liver Fat Content in Non-alcoholic Fatty Liver Disease

Tehran University of Medical Sciences100 enrolled

Overview

The role of Helicobacter pylori(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. Liver fat content, fasting serum glucose, alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, triglyceride, cholesterol, high and low-density lipoprotein,homeostasis model assessment-insulin resistance(HOMA-IR), and anthropometric measurements (body mass index and waist circumference) were checked at baseline and six months later.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

100

Conditions

Fatty Liver Liver Dysfunction Insulin Resistance

Interventions

H.pylori eradication (Omeprazole, Amoxicillin, Bismuth subcitrate, Azithromycin)DRUG

The regimen consists of Omeprazole (20 mg/BD)+ Amoxicillin (1 g/day)+ Bismuth subcitrate (240 mg/BD)+ Azithromycin (500 mg/BD)for two weeks.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * dyspeptic patients with positive antibody to H.pylori and * persistent elevated aminotransferase levels with the evidence of fatty liver in ultrasonography, who were referred to a gastroenterology clinic. Exclusion Criteria: * alcohol use (more than 20 gram per day in men and 10 gram per day in women per day), * heart disease (ischemic or congestive), * hepatic disease (viral hepatitis, autoimmune hepatitis, wilson disease, hemochromatosis, liver mass lesion), * renal disease (serum creatinine concentration of \> 1.5 mg/dl), * any severe systemic co-morbidities, neoplasm, * using any hepatotoxic medication during the past 3 months, * previous history of peptic ulcer, * previous history of H.pylori eradication, * existence of alarm signs (weight loss, dysphagia, anemia, vomiting, positive family history of gastrointestinal cancers), and * pregnant or lactating women.

Locations (1)

Gastroenterology clinic, Sina Hospital

Tehran, Tehran Province, Iran

Outcomes

Primary Outcomes

Change from baseline liver fat content at 6 months

Time frame: 6 months

Secondary Outcomes

Change from baseline liver function tests at 6 months

Time frame: 6 months

Data from ClinicalTrials.gov

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