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Completed

NCT Number: NCT01654549

Helicobacter Pylori Eradication in Non-diabetic Non-alcoholic Steatohepatitis

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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Gastroenterology clinic, Sina hospital.

Tehran, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

H.pylori eradication

Drug

Omeprazole (20 mg/BD)+ Amoxicillin (1 g/day)+ Bismuth subcitrate (240 mg/BD)+ Azithromycin (500 mg/BD)

Other names: H.pylori treatment

Primary outcomes

  1. Liver Fat Content

    Time frame: 8 weeks (6 weeks post-treatment)

    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 outcomes

  1. Serum Alanine Aminotransferase Level

    Time frame: 8 weeks

    Secondary outcome measure was change in serum alanine aminotransferase concentration from baseline to the end of study

  2. Serum Aspartate Aminotransferase Level

    Time frame: 8 weeks

    Secondary outcome measure was change in serum aspartate aminotransferase concentration from baseline to the end of study

  3. Fasting Serum Glucose

    Time frame: 8 weeks

    Secondary outcome measure was change in fasting serum glucose concentration from baseline to the end of study

  4. Serum Lipid Profile

    Time frame: 8 weeks

    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

  5. Homeostasis Model Assessment-Insulin Resistance (HOMA-IR)

    Time frame: 8 weeks

    Secondary outcome measure was change in HOMA-IR from baseline to the end of study

  6. Anthropometric Measurements

    Time frame: 8 weeks

    Secondary outcome measure was change in anthropometric measurements (body mass index and waist circumference) from baseline to the end of study

Sponsors and collaborators

Lead sponsor

Tehran University of Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jul 31, 2012
Registry last updated
Jun 28, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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