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Trial record 14 of 356 for:    hepatic steatosis AND fat AND Nonalcoholic Fatty Liver

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

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ClinicalTrials.gov Identifier: NCT01876108
Recruitment Status : Completed
First Posted : June 12, 2013
Last Update Posted : July 8, 2013
Sponsor:
Information provided by (Responsible Party):
Raika Jamali, MD, Tehran University of Medical Sciences

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

Condition or disease Intervention/treatment Phase
Fatty Liver Liver Dysfunction Insulin Resistance Drug: H.pylori eradication (Omeprazole, Amoxicillin, Bismuth subcitrate, Azithromycin) Phase 2

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.

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


Arm Intervention/treatment
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, Amoxicillin, Bismuth subcitrate, Azithromycin)
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: H.pylori treatment

No Intervention: Lifestyle modification
Obtaining ideal body weight by calorie restriction diet and programmed physical activity



Primary Outcome Measures :
  1. Change from baseline liver fat content at 6 months [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Change from baseline liver function tests at 6 months [ Time Frame: 6 months ]

Other Outcome Measures:
  1. Change from baseline insulin resistance at 6 months [ Time Frame: 6 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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),
  • 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.

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): NCT01876108


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

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Responsible Party: Raika Jamali, MD, Assistant Professor of Medicine, Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01876108     History of Changes
Other Study ID Numbers: 1392/3/11- 589
First Posted: June 12, 2013    Key Record Dates
Last Update Posted: July 8, 2013
Last Verified: July 2013

Keywords provided by Raika Jamali, MD, Tehran University of Medical Sciences:
Steatohepatitis
Helicobacter pylori
Alanine aminotransferase
Aspartate aminotransferase
Fatty Liver
Liver Diseases
Digestive System Diseases

Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Digestive System Diseases
Amoxicillin
Bismuth tripotassium dicitrate
Omeprazole
Bismuth
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antacids