Effect of Eradication of Helicobacter Pylori on the Dyspeptic Symptoms

NCT ID: NCT00772837

Last Updated: 2009-11-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 370 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-08-31
• Study Completion Date: 2009-01-31

Brief Summary

Helicobacter pylori eradication and its impact on symptoms in patients with non-ulcer dyspepsia remain controversial . Many studies have examined the effect of H. pylori eradication on dyspeptic symptoms, but the results have been conflicting and inconclusive, with as many studies yielding positive as negative results. Some studies have shown a significant (although weak) symptomatic improvement after H. pylori eradication, and while other yielding negative results. A recent Cochrane review has comprehensively demonstrated that H.pylori eradication therapy has a small but statistically significant effect in H.pylori positive non-ulcer dyspepsia. An economic model suggests this modest benefit may still be cost effective . However it is difficult to reconcile these results in areas with very high prevalence of H. pylori infection such as Pakistan since no such studies have been conducted in developing countries.

The investigators hypothesize that eradication of Helicobacter pylori (H. pylori) leads to a sustained improvement in symptoms of patients diagnosed with H. pylori associated functional (non-ulcer) dyspepsia.

Conditions

Functional Dyspepsia; Helicobacter Pylori Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

1.H.Pylori Eradication Group

The eradication group will receive triple therapy (omeprazole 20mg BID for 1 week along with Clarithromycin 500mg BID and Amoxycillin 1g BID) for 1 week for the eradication of H. pylori

Group Type: EXPERIMENTAL

Omeprazole + Clarithromycin + Amoxycillin

Intervention Type: DRUG

Omeprazole 20mg BID for 1 week along with Clarithromycin 500mg BD and Amoxycillin 1g BD for 1 week

2.Control Placebo Group

The control group will receive omeprazole 20 mg BID for 1 week along with placebo antibiotics for 1 week

Group Type: PLACEBO_COMPARATOR

Omeprazole + placebo antibiotics

Intervention Type: DRUG

omeprazole 20 mg bid for 1 week along with placebo antibiotics for 1 week

Interventions

Omeprazole + Clarithromycin + Amoxycillin

Omeprazole 20mg BID for 1 week along with Clarithromycin 500mg BD and Amoxycillin 1g BD for 1 week

Intervention Type: DRUG

Omeprazole + placebo antibiotics

omeprazole 20 mg bid for 1 week along with placebo antibiotics for 1 week

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Ambulatory adult males and non-pregnant females.
• Dyspeptic symptoms for at least 3 months.
• Normal endoscopic findings.
• H. Pylori positive on testing.

Exclusion Criteria

• Patients with erosive and non erosive esophagitis.
• Barrette's esophagus.
• Duodenal Ulcer, Gastric Ulcer or gastric erosions.
• Patients with known sensitivity to antibiotics.
• Patients with severe concomitant systemic disease.
• Patients with upper GI surgery except cholecystectomy.
• Females with pregnancy or breast-feeding.
• Malignancy
• Alarm symptoms such as bleeding per rectum, hematemesis, and severe weight loss.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aga Khan University

OTHER

Sponsor Role: lead

Responsible Party

SECTION OF GASTROENTEROLY,DEPARTMENT OF MEDICINE,AGA KHAN UNIVERSITY

Principal Investigators

DR.SHAHAB ABID, MD

Role: PRINCIPAL_INVESTIGATOR

Aga Khan University

Locations

Aga khan University

Karachi, Sindh, Pakistan

Countries

Pakistan

Other Identifiers

602-Med/ERC-06

Identifier Type: -

Identifier Source: org_study_id