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

NCT01876108 | Completed Phase 2 DMC

• 1 other identifier: 1392/3/11- 589
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Fatty Liver; Liver Dysfunction; Insulin Resistance

Keywords

Steatohepatitis; Helicobacter pylori; Alanine aminotransferase; Aspartate aminotransferase; Fatty Liver; Liver Diseases; Digestive System Diseases

Outcome Measures

Primary Outcomes (1)

• Change from baseline liver fat content at 6 months

  6 months

Secondary Outcomes (1)

• Change from baseline liver function tests at 6 months

  6 months

Other Outcomes (1)

• Change from baseline insulin resistance at 6 months

  6 months

Study Arms (2)

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 (Omeprazole, Amoxicillin, Bismuth subcitrate, Azithromycin)

Lifestyle modification

NO INTERVENTION

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

Interventions

H.pylori eradication (Omeprazole, Amoxicillin, Bismuth subcitrate, Azithromycin) 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: H.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,
• existence of alarm signs (weight loss, dysphagia, anemia, vomiting, positive family history of gastrointestinal cancers), and
• pregnant or lactating women.

Sponsors & Collaborators

• Tehran University of Medical Sciences: lead

Study Sites (1)

Gastroenterology clinic, Sina Hospital

Tehran, Tehran Province, Iran

Location

MeSH Terms

Conditions

Fatty Liver; Liver Diseases; Insulin Resistance; Digestive System Diseases

Interventions

Omeprazole; Amoxicillin; bismuth tripotassium dicitrate; Azithromycin

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Erythromycin; Macrolides; Polyketides; Lactones

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: CARE PROVIDER, 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: June 8, 2013
• First Posted: June 12, 2013
• Study Start: July 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: July 8, 2013

Record last verified: 2013-07

Locations

IR (1)