Effect of Eradication of Helicobacter Pylori on the Dyspeptic Symptoms

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Eradication of Helicobacter Pylori on the Dyspeptic Symptoms.

Conditions
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Functional Dyspepsia, Helicobacter Pylori Infection

Intervention / Treatment
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* Drug: Omeprazole + Clarithromycin + Amoxycillin
* Drug: Omeprazole + placebo antibiotics


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1.H.Pylori Eradication Group<br>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<br>* Omeprazole 20mg BID for 1 week along with Clarithromycin 500mg BD and Amoxycillin 1g BD for 1 week<br>|
| Placebo Comparator: 2.Control Placebo Group<br>The control group will receive omeprazole 20 mg BID for 1 week along with placebo antibiotics for 1 week | Drug: Omeprazole + placebo antibiotics<br>* omeprazole 20 mg bid for 1 week along with placebo antibiotics for 1 week<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Functional Dyspepsia, Helicobacter Pylori eradication, Quality of Life, Dyspeptic Symptoms