Helicobacter Pylori Empiric Treatment in Ulcer Bleeding

Hospital de Sabadell178 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

178

Conditions

Peptic Ulcer Hemorrhage

Interventions

Empirical Hp eradicationOTHER

Empirical Helicobacter pylori treatment initiated immediately after oral intake is resumed

Eradication treatment guided by a positive testOTHER

Eradication treatment given if there is at least one positive diagnostic test (URT, histological test, breath test or serology) for Helicobacter pylori.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Hospital de Sabadell, Institut Universitari Parc Tauli

Sabadell, Barcelona, Spain

RECRUITING

Outcomes

Primary Outcomes

Helicobacter pylori eradication rate

Time frame: two years

Secondary Outcomes

Economical evaluation through cost-effectivity study of the empiric erradicator Helicobacter pylori treatment.

Time frame: two years

Central Contacts

Pilar Garcia, Dra.

CONTACT

34-93-723-1010 pgarciai@telefonica.net

Xavier Calvet, Dr.

CONTACT

34-93-723-1010 xcalvet@tauli.cat

Data from ClinicalTrials.gov

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