Effect of Eradication of Helicobacter Pylori on the Dyspeptic Symptoms

Helicobacter Pylori Infection Clinical Trial

— EEHPDS  

Official title:

Effect of Eradication of Helicobacter Pylori on the Dyspeptic Symptoms.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00772837
• Other study ID #: 602-Med/ERC-06
• Status: Completed
• Phase: N/A
• First received: October 14, 2008
• Last updated: November 9, 2009
• Start date: August 2006
• Est. completion date: January 2009

Study information

• Verified date: November 2009
• Source: Aga Khan University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Pakistan: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 370
• Est. completion date: January 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyspepsia
• Functional Dyspepsia
• Helicobacter Infections
• Helicobacter Pylori Infection

Intervention

Drug:
• Omeprazole + Clarithromycin + Amoxycillin
Omeprazole 20mg BID for 1 week along with Clarithromycin 500mg BD and Amoxycillin 1g BD for 1 week
• Omeprazole + placebo antibiotics
omeprazole 20 mg bid for 1 week along with placebo antibiotics for 1 week

Locations

Country	Name	City	State
Pakistan	Aga khan University	Karachi	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
Aga Khan University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in Dyspeptic Symptoms after eradication of Helicobacter Pylori in Patients with Functional Dyspepsia		1 year	No
Secondary	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	No