Clinical trial NCT01876108: The Effect of Helicobacter Pylori Eradication on Liver Fat Content in Non-alcoholic Fatty Liver Disease
Official title: The Effect of Helicobacter Pylori Eradication on Liver Fat Content in Subjects With Non-alcoholic Fatty Liver Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Fatty Liver
Liver Dysfunction
Insulin Resistance
Keywords: Steatohepatitis
Helicobacter pylori
Alanine aminotransferase
Aspartate aminotransferase
Fatty Liver
Liver Diseases
Digestive System Diseases
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
First posted: 2013-06-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The role of Helicobacter pylori(HP)in the pathogenesis of non-alcoholic fatty liver disease (NAFLD) is controversial.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline liver fat content at 6 months
timeFrame: 6 months
Secondary outcomes:
measure: Change from baseline liver function tests at 6 months
timeFrame: 6 months
Other outcomes:
measure: Change from baseline insulin resistance at 6 months
timeFrame: 6 months
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Gastroenterology clinic, Sina Hospital
Study officials:
affiliation: Tehran University of Medical Sciences
name: Raika Jamali, M.D.
role: PRINCIPAL_INVESTIGATOR
References: