Helicobacter Pylori Empiric Treatment in Ulcer Bleeding

Phase 4

• Conditions: Peptic Ulcer Hemorrhage
• Interventions: Other: Empirical Hp eradication; Other: Eradication treatment guided by a positive test

• Registration Number: NCT00687336
• Lead Sponsor: Hospital de Sabadell

Brief Summary

The goal of the study is to compare the effectiveness of empirical Helicobacter pylori treatment compared with treatment depending on diagnostic tests for Helicobacter pylori in patients with Upper gastrointestinal bleeding due to peptic ulcer. Main hypothesis is that empirical treatment will reduce the number of patients lost to follow-up thus improving the cure rates of Hp infection.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2008-05-27
• Study First Submitted QC: 2008-05-29
• Study First Posted: 2008-05-30
• Status Verified: 2009-07
• Last Update Submitted: 2009-07-07
• Last Update Posted: 2009-07-08
• Primary Completion: 2010-05
• Study Completion: 2010-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 178

Inclusion Criteria

• Patients older than 18.
• Informed Consent signed.
• Diagnosis of no variceal upper gastrointestinal bleeding secondary to a duodenal ulcer, erosive duodenitis or gastric ulcer.
• Life expectancy longer than 6 months.
• Able to attend further clinical controls.
• Absence of the following exclusion criteria.

Exclusion Criteria

• Previous eradication treatment.
• Use of antibiotics 2 weeks prior to inclusion.
• Need for Antisecretor treatment that cannot be stopped to perform the breath test.
• Pregnancy or breastfeeding.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Empirical Hp eradication	Empirical eradication treatment
2	Eradication treatment guided by a positive test	Eradication treatment according to a diagnostic test (URT, histological test, breath test or serology).

Primary Outcome Measures

Name	Time	Method
Helicobacter pylori eradication rate	two years

Secondary Outcome Measures

Name	Time	Method
Economical evaluation through cost-effectivity study of the empiric erradicator Helicobacter pylori treatment.	two years

Trial Locations

Locations (1)

Hospital de Sabadell, Institut Universitari Parc Tauli; 🇪🇸 Sabadell, Barcelona, Spain