Effect of Eradication of Helicobacter Pylori on the Dyspeptic Symptoms (EEHPDS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00772837
Recruitment Status : Completed
First Posted : October 15, 2008
Last Update Posted : November 10, 2009
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Functional Dyspepsia Helicobacter Pylori Infection Drug: Omeprazole + Clarithromycin + Amoxycillin Drug: Omeprazole + placebo antibiotics Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 370 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Eradication of Helicobacter Pylori on the Dyspeptic Symptoms.
Study Start Date : August 2006
Actual Primary Completion Date : December 2008
Actual Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Indigestion

Arm Intervention/treatment
Experimental: 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
Drug: Omeprazole + Clarithromycin + Amoxycillin
Omeprazole 20mg BID for 1 week along with Clarithromycin 500mg BD and Amoxycillin 1g BD for 1 week

Placebo Comparator: 2.Control Placebo Group
The control group will receive omeprazole 20 mg BID for 1 week along with placebo antibiotics for 1 week
Drug: Omeprazole + placebo antibiotics
omeprazole 20 mg bid for 1 week along with placebo antibiotics for 1 week

Primary Outcome Measures :
  1. Improvement in Dyspeptic Symptoms after eradication of Helicobacter Pylori in Patients with Functional Dyspepsia [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. 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. [ Time Frame: 1 year ]

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00772837

Aga khan University
Karachi, Sindh, Pakistan, 74800
Sponsors and Collaborators
Aga Khan University
Principal Investigator: DR.SHAHAB ABID, MD Aga Khan University

Other Study ID Numbers: 602-Med/ERC-06
First Posted: October 15, 2008    Key Record Dates
Last Update Posted: November 10, 2009
Last Verified: November 2009

Keywords provided by Aga Khan University:
Functional Dyspepsia
Helicobacter Pylori eradication
Quality of Life
Dyspeptic Symptoms

Additional relevant MeSH terms:
Helicobacter Infections
Signs and Symptoms, Digestive
Signs and Symptoms
Gram-Negative Bacterial Infections
Bacterial Infections
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protein Synthesis Inhibitors
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors