Helicobacter Pylori Eradication in Non-diabetic Non-alcoholic Steatohepatitis

Non-alcoholic Fatty Liver Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01654549
• Other study ID #: 1391/3/27-573
• Status: Completed
• Phase: Phase 2
• Start date: April 2012
• Est. completion date: September 2012

Study information

• Verified date: April 2018
• Source: Tehran University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Non-alcoholic Fatty Liver Disease

Intervention

Drug:
• H.pylori eradication
Omeprazole (20 mg/BD)+ Amoxicillin (1 g/day)+ Bismuth subcitrate (240 mg/BD)+ Azithromycin (500 mg/BD)

Locations

Country	Name	City	State
Iran, Islamic Republic of	Gastroenterology clinic, Sina hospital.	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Tehran University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Liver Fat Content	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)"	8 weeks (6 weeks post-treatment)
Secondary	Serum Alanine Aminotransferase Level	Secondary outcome measure was change in serum alanine aminotransferase concentration from baseline to the end of study	8 weeks
Secondary	Serum Aspartate Aminotransferase Level	Secondary outcome measure was change in serum aspartate aminotransferase concentration from baseline to the end of study	8 weeks
Secondary	Fasting Serum Glucose	Secondary outcome measure was change in fasting serum glucose concentration from baseline to the end of study	8 weeks
Secondary	Serum Lipid Profile	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	8 weeks
Secondary	Homeostasis Model Assessment-Insulin Resistance (HOMA-IR)	Secondary outcome measure was change in HOMA-IR from baseline to the end of study	8 weeks
Secondary	Anthropometric Measurements	Secondary outcome measure was change in anthropometric measurements (body mass index and waist circumference) from baseline to the end of study	8 weeks