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

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.

Study Overview

• Status: Completed
• Conditions: Functional Dyspepsia; Helicobacter Pylori Infection
• Intervention / Treatment: Drug: Omeprazole + Clarithromycin + Amoxycillin; Drug: Omeprazole + placebo antibiotics

• Study Type: Interventional
• Enrollment (Actual): 370
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan, 74800
      • Aga Khan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Improvement in Dyspeptic Symptoms after eradication of Helicobacter Pylori in Patients with Functional Dyspepsia	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
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.	1 year

Collaborators and Investigators

• Sponsor: Aga Khan University
• Investigators: Principal Investigator: DR.SHAHAB ABID, MD, Aga Khan University

Study record dates

Study Major Dates

• Study Start: August 1, 2006
• Primary Completion (ACTUAL): December 1, 2008
• Study Completion (ACTUAL): January 1, 2009

Study Registration Dates

• First Submitted: October 14, 2008
• First Submitted That Met QC Criteria: October 14, 2008
• First Posted (ESTIMATE): October 15, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): November 10, 2009
• Last Update Submitted That Met QC Criteria: November 9, 2009
• Last Verified: November 1, 2009

More Information

Terms related to this study

• Keywords: Quality of Life; Functional Dyspepsia; Helicobacter Pylori eradication; Dyspeptic Symptoms
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Dyspepsia; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Gastrointestinal Agents; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Protein Synthesis Inhibitors; Anti-Ulcer Agents; Proton Pump Inhibitors; Anti-Bacterial Agents; Amoxicillin; Clarithromycin; Omeprazole
• Other Study ID Numbers: 602-Med/ERC-06