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Effect of Eradication of Helicobacter Pylori on the Dyspeptic Symptoms

NCT00772837 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 370

Last updated 2009-11-10

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Aga Khan University

    lead OTHER

Principal Investigators

  • DR.SHAHAB ABID, MD · Aga Khan University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-08-31
Primary Completion
2008-12-31
Completion
2009-01-31

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00772837 on ClinicalTrials.gov