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

NCT01759628 | Completed Phase 2 DMC

• 1 other identifier: 91138 - KAUMS
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-alcoholic Fatty Liver Disease

Keywords

Steatohepatitis,; Helicobacter pylori,; Insulin resistance,; Alanine aminotransferase,; Aspartate aminotransferase,

Outcome Measures

Primary Outcomes (1)

• Change from Baseline liver function tests at Twelve weeks

  Twelve weeks

Secondary Outcomes (1)

• Change of insulin resistance and lipid profile during the study period

  Twelve weeks

Study Arms (2)

Lifestyle modification

NO INTERVENTION

Obtaining ideal body weight by calorie restriction diet and programmed physical activity

H.pylori eradication

EXPERIMENTAL

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

Interventions

H.pylori eradication DRUG

The regimen consists of Omeprazole (20 mg/BD)+ Amoxicillin (1 g/day)+ Bismuth subcitrate (240 mg/BD)+ Azithromycin (500 mg/BD)for two weeks

Also known as: Helicobacter pylori treatment

H.pylori eradication

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tehran University of Medical Sciences: lead
• Kashan University of Medical Sciences: collaborator

Study Sites (1)

Gastroenterology clinic, Sina Hospital (Tehran) / Beheshti Hospital (Kashan)

Tehran / Kashan, Iran

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Fatty Liver; Insulin Resistance

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Raika Jamali, M.D.

  Tehran University of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: December 20, 2012
• First Posted: January 3, 2013
• Study Start: April 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: June 13, 2013

Record last verified: 2013-06

Locations

IR (1)