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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00772837
First Posted: October 15, 2008
Last Update Posted: November 10, 2009
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.
Information provided by:
Aga Khan University
October 14, 2008
October 15, 2008
November 10, 2009
August 2006
December 2008   (Final data collection date for primary outcome measure)
Improvement in Dyspeptic Symptoms after eradication of Helicobacter Pylori in Patients with Functional Dyspepsia [ Time Frame: 1 year ]
Same as current
Complete list of historical versions of study NCT00772837 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Effect of Eradication of Helicobacter Pylori on the Dyspeptic Symptoms
Effect of Eradication of Helicobacter Pylori on the Dyspeptic Symptoms.

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
  • Functional Dyspepsia
  • Helicobacter Pylori Infection
  • 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
  • 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
    Intervention: Drug: Omeprazole + Clarithromycin + Amoxycillin
  • 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
    Intervention: Drug: Omeprazole + placebo antibiotics
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
370
January 2009
December 2008   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Pakistan
 
 
NCT00772837
602-Med/ERC-06
No
Not Provided
Not Provided
DR.SHAHAB ABID, SECTION OF GASTROENTEROLY,DEPARTMENT OF MEDICINE,AGA KHAN UNIVERSITY
Aga Khan University
Not Provided
Principal Investigator: DR.SHAHAB ABID, MD Aga Khan University
Aga Khan University
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP