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

This study has been completed.
Sponsor:
Information provided by:
Aga Khan University
ClinicalTrials.gov Identifier:
NCT00772837
First received: October 14, 2008
Last updated: November 9, 2009
Last verified: November 2009
  Purpose

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 Intervention
Functional Dyspepsia
Helicobacter Pylori Infection
Drug: Omeprazole + Clarithromycin + Amoxycillin
Drug: Omeprazole + placebo antibiotics

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Eradication of Helicobacter Pylori on the Dyspeptic Symptoms.

Resource links provided by NLM:


Further study details as provided by Aga Khan University:

Primary Outcome Measures:
  • Improvement in Dyspeptic Symptoms after eradication of Helicobacter Pylori in Patients with Functional Dyspepsia [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 370
Study Start Date: August 2006
Study Completion Date: January 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00772837

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

No publications provided

Responsible Party: DR.SHAHAB ABID, SECTION OF GASTROENTEROLY,DEPARTMENT OF MEDICINE,AGA KHAN UNIVERSITY
ClinicalTrials.gov Identifier: NCT00772837     History of Changes
Other Study ID Numbers: 602-Med/ERC-06
Study First Received: October 14, 2008
Last Updated: November 9, 2009
Health Authority: Pakistan: Research Ethics Committee

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

Additional relevant MeSH terms:
Dyspepsia
Gastritis
Helicobacter Infections
Signs and Symptoms, Digestive
Signs and Symptoms
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Gram-Negative Bacterial Infections
Bacterial Infections
Amoxicillin
Anti-Bacterial Agents
Clarithromycin
Antibiotics, Antitubercular
Omeprazole
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents
Anti-Ulcer Agents
Gastrointestinal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protein Synthesis Inhibitors

ClinicalTrials.gov processed this record on July 26, 2014