NCT00772837

Effect of Eradication of Helicobacter Pylori on the Dyspeptic Symptoms

Effect of Eradication of Helicobacter Pylori on the Dyspeptic Symptoms.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 370 (actual)
• Sponsor: Aga Khan University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Omeprazole + Clarithromycin + Amoxycillin	Omeprazole 20mg BID for 1 week along with Clarithromycin 500mg BD and Amoxycillin 1g BD for 1 week
DRUG	Omeprazole + placebo antibiotics	omeprazole 20 mg bid for 1 week along with placebo antibiotics for 1 week

Timeline

• Start date: 2006-08-01
• Primary completion: 2008-12-01
• Completion: 2009-01-01
• First posted: 2008-10-15
• Last updated: 2009-11-10

Locations

1 site across 1 country: Pakistan