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

Primary Purpose

Functional Dyspepsia, Helicobacter Pylori Infection

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Omeprazole + Clarithromycin + Amoxycillin
Omeprazole + placebo antibiotics
Sponsored by
Aga Khan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Functional Dyspepsia focused on measuring Functional Dyspepsia, Helicobacter Pylori eradication, Quality of Life, Dyspeptic Symptoms

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Aga khan University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1.H.Pylori Eradication Group

2.Control Placebo Group

Arm Description

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

The control group will receive omeprazole 20 mg BID for 1 week along with placebo antibiotics for 1 week

Outcomes

Primary Outcome Measures

Improvement in Dyspeptic Symptoms after eradication of Helicobacter Pylori in Patients with Functional Dyspepsia

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.

Full Information

First Posted
October 14, 2008
Last Updated
November 9, 2009
Sponsor
Aga Khan University
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1. Study Identification

Unique Protocol Identification Number
NCT00772837
Brief Title
Effect of Eradication of Helicobacter Pylori on the Dyspeptic Symptoms
Acronym
EEHPDS
Official Title
Effect of Eradication of Helicobacter Pylori on the Dyspeptic Symptoms.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2009
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
January 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Aga Khan University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Dyspepsia, Helicobacter Pylori Infection
Keywords
Functional Dyspepsia, Helicobacter Pylori eradication, Quality of Life, Dyspeptic Symptoms

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
370 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1.H.Pylori Eradication Group
Arm Type
Experimental
Arm Description
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
Arm Title
2.Control Placebo Group
Arm Type
Placebo Comparator
Arm Description
The control group will receive omeprazole 20 mg BID for 1 week along with placebo antibiotics for 1 week
Intervention Type
Drug
Intervention Name(s)
Omeprazole + Clarithromycin + Amoxycillin
Intervention Description
Omeprazole 20mg BID for 1 week along with Clarithromycin 500mg BD and Amoxycillin 1g BD for 1 week
Intervention Type
Drug
Intervention Name(s)
Omeprazole + placebo antibiotics
Intervention Description
omeprazole 20 mg bid for 1 week along with placebo antibiotics for 1 week
Primary Outcome Measure Information:
Title
Improvement in Dyspeptic Symptoms after eradication of Helicobacter Pylori in Patients with Functional Dyspepsia
Time Frame
1 year
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
DR.SHAHAB ABID, MD
Organizational Affiliation
Aga Khan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aga khan University
City
Karachi
State/Province
Sindh
ZIP/Postal Code
74800
Country
Pakistan

12. IPD Sharing Statement

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Effect of Eradication of Helicobacter Pylori on the Dyspeptic Symptoms

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