Effect of Eradication of Helicobacter Pylori on the Dyspeptic Symptoms

Not Applicable

Completed

• Conditions: Functional Dyspepsia; Helicobacter Pylori Infection
• Interventions: Drug: Omeprazole + Clarithromycin + Amoxycillin; Drug: Omeprazole + placebo antibiotics

• Registration Number: NCT00772837
• Lead Sponsor: Aga Khan University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-08
• Study First Submitted: 2008-10-14
• Study First Submitted QC: 2008-10-14
• Study First Posted: 2008-10-15
• Primary Completion: 2008-12
• Study Completion: 2009-01
• Status Verified: 2009-11
• Last Update Submitted: 2009-11-09
• Last Update Posted: 2009-11-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 370

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1.H.Pylori Eradication Group	Omeprazole + Clarithromycin + Amoxycillin	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
2.Control Placebo Group	Omeprazole + placebo antibiotics	The control group will receive omeprazole 20 mg BID for 1 week along with placebo antibiotics for 1 week

Primary Outcome Measures

Name	Time	Method
Improvement in Dyspeptic Symptoms after eradication of Helicobacter Pylori in Patients with Functional Dyspepsia	1 year

Secondary Outcome Measures

Name	Time	Method
To determine whether eradication of Helicobacter Pylori improves the quality of life in patients with Functional Dyspepsia i.Quality of life (QoL) assessment on the basis of SF-36.	1 year

Trial Locations

Locations (1)

Aga khan University; 🇵🇰 Karachi, Sindh, Pakistan