Helicobacter Pylori Eradication in Non-diabetic Non-alcoholic Steatohepatitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Raika Jamali, Tehran University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01654549
First received: July 27, 2012
Last updated: November 21, 2012
Last verified: November 2012
  Purpose

The aim of study was to evaluate the effect of helicobacter pylori eradication on liver fat content, liver function tests, lipid profile, homeostasis model assessment-IR (HOMA-IR) index, and anthropometric measurements (body mass index and waist circumference)in non-diabetic subjects with non-alcoholic fatty liver disease.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Helicobacter Pylori Eradication on Liver Fat Content in Non-diabetic Subjects With Non-alcoholic Fatty Liver Disease

Resource links provided by NLM:


Further study details as provided by Tehran University of Medical Sciences:

Primary Outcome Measures:
  • Liver Fat Content [ Time Frame: 8 weeks (6 weeks post-treatment) ] [ Designated as safety issue: No ]

    Primary outcome measure was changes in the liver fat content from baseline to the end of study (6 weeks post-treatment).

    The percent of liver fat was calculated as below:

    "Liver fat content (%) = 10 (-0.805 + 0.282 * metabolic syndrome (yes = 1 / no = 0) + 0.078 * type 2 diabetes (yes =2 / no =0) + 0.525 * log fasting serum insulin (mU/L) + 0.521 * log fasting serum AST (U/L) - 0.454 * log (AST/ALT)"



Secondary Outcome Measures:
  • Serum Alanine Aminotransferase Level [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Secondary outcome measure was change in serum alanine aminotransferase concentration from baseline to the end of study

  • Serum Aspartate Aminotransferase Level [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Secondary outcome measure was change in serum aspartate aminotransferase concentration from baseline to the end of study

  • Fasting Serum Glucose [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Secondary outcome measure was change in fasting serum glucose concentration from baseline to the end of study

  • Serum Lipid Profile [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Secondary outcome measure was change in serum lipid profile (including serum triglyceride, cholesterol, low-density lipoprotein, and high-density lipoprotein concentration) from baseline to the end of study

  • Homeostasis Model Assessment-Insulin Resistance (HOMA-IR) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Secondary outcome measure was change in HOMA-IR from baseline to the end of study

  • Anthropometric Measurements [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Secondary outcome measure was change in anthropometric measurements (body mass index and waist circumference) from baseline to the end of study


Enrollment: 40
Study Start Date: April 2012
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Omeprazole (20 mg/BD)+ Amoxicillin (1 g/day)+ Bismuth subcitrate (240 mg/BD)+ Azithromycin (500 mg/BD)
Other Name: H.pylori treatment

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 non-diabetic 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, HOMA-IR, and anthropometric measurements (body mass index and waist circumference) were checked at baseline and six weeks post-treatment.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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), diabetes mellitus, 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 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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01654549

Locations
Iran, Islamic Republic of
Gastroenterology clinic, Sina hospital.
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
Tehran University of Medical Sciences
Investigators
Principal Investigator: Raika Jamali, M.D. Tehran University of Medical Sciences
  More Information

No publications provided

Responsible Party: Raika Jamali, Assistant professor of medicine, Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01654549     History of Changes
Other Study ID Numbers: 1391/3/27-573
Study First Received: July 27, 2012
Results First Received: October 20, 2012
Last Updated: November 21, 2012
Health Authority: Iran: Ministry of Health

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

Additional relevant MeSH terms:
Fatty Liver
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on July 20, 2014