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Helicobacter Pylori Eradication in Subjects With Non-alcoholic Fatty Liver Disease

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ClinicalTrials.gov Identifier: NCT01759628
Recruitment Status : Completed
First Posted : January 3, 2013
Last Update Posted : June 13, 2013
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Non-alcoholic Fatty Liver Disease Drug: H.pylori eradication Phase 2

Detailed Description:

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Helicobacter Pylori Eradication on Liver Function Tests in Subjects With Non-alcoholic Fatty Liver Disease
Study Start Date : April 2012
Primary Completion Date : June 2013
Study Completion Date : June 2013

Arms and Interventions

Arm Intervention/treatment
No Intervention: Lifestyle modification
Obtaining ideal body weight by calorie restriction diet and programmed physical activity
Experimental: H.pylori eradication
H.pylori eradication by quadruple antibiotic therapy for two weeks plus obtaining ideal body weight by calorie restriction diet and programmed physical activity
Drug: H.pylori eradication
The regimen consists of Omeprazole (20 mg/BD)+ Amoxicillin (1 g/day)+ Bismuth subcitrate (240 mg/BD)+ Azithromycin (500 mg/BD)for two weeks
Other Name: Helicobacter pylori treatment

Outcome Measures

Primary Outcome Measures :
  1. Change from Baseline liver function tests at Twelve weeks [ Time Frame: Twelve weeks ]

Secondary Outcome Measures :
  1. Change of insulin resistance and lipid profile during the study period [ Time Frame: Twelve weeks ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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, and pregnant or lactating women.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01759628

Iran, Islamic Republic of
Gastroenterology clinic, Sina Hospital (Tehran) / Beheshti Hospital (Kashan)
Tehran / Kashan, Iran, Islamic Republic of
Sponsors and Collaborators
Tehran University of Medical Sciences
Kashan University of Medical Sciences
Principal Investigator: Raika Jamali, M.D. Tehran University of Medical Sciences
More Information

Responsible Party: Raika Jamali, MD, Assistant Professor of Medicine, Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01759628     History of Changes
Other Study ID Numbers: 91138 - KAUMS
First Posted: January 3, 2013    Key Record Dates
Last Update Posted: June 13, 2013
Last Verified: June 2013

Keywords provided by Raika Jamali, MD, Tehran University of Medical Sciences:
Helicobacter pylori,
Insulin resistance,
Alanine aminotransferase,
Aspartate aminotransferase,

Additional relevant MeSH terms:
Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases