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

Aga Khan University

Status: Completed

Conditions: Functional Dyspepsia; Helicobacter Pylori Infection

Treatments: Drug: Omeprazole + Clarithromycin + Amoxycillin; Drug: Omeprazole + placebo antibiotics

Study type: Interventional

Funder types: Other

Identifiers

NCT00772837

602-Med/ERC-06

Details and patient eligibility

About

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.

Enrollment: 370 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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370 participants in 2 patient groups, including a placebo group

1.H.Pylori Eradication Group

Experimental group

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

Treatment:

Drug: Omeprazole + Clarithromycin + Amoxycillin

2.Control Placebo Group

Placebo Comparator group

Description:

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

Treatment:

Drug: Omeprazole + placebo antibiotics