About this trial
The great diversity of regimens and treatment lines, the different efficacy of these, mostly due to the increase in bacterial antibiotic resistance and regional differences, requires a continuous critical analysis of clinical practice, evaluating systematically the efficacy and safety of the different regimens and the cost-effectiveness of the different diagnostic-therapeutic strategies. This will help in the design of an efficient and optimized treatment that will reduce number of re-treatments, diagnostic tests and the appearance of associated pathologies such as peptic ulcers, gastrointestinal bleeding and, probably, gastric cancers. Therefore, the evaluation of real clinical practice using non-interventionist registries will help to improve the design and organization of European Consensus on the management of H. pylori infection, which is the best way to establish healthcare efficiency.
Primary aim
To obtain a database registering systematically over a year a large and representative sample of routine clinical practice of European gastroenterologists in order to produce descriptive studies of the management of H. pylori infection.
Secondary aims
1. To evaluate H. pylori infection consensus and clinical guidelines implementation in different countries. 2. To perform studies focused on epidemiology, efficacy and safety of the commonly used treatments to eradicate H. pylori. 3. To evaluate accessibility to healthcare technologies and drugs used in the management of H. pylori infection. 4. To allow the development of partial and specific analysis by the participating researchers after approval by the Registry's Scientific Committee
Methodology Non-interventionist prospective multicentre international registry promoted by the European Helicobacter Study Group. A renowned gastroenterologist from each country was selected as Local Coordinator (30 countries). They will in turn select up to ten gastroenterologists per country that will register the routine clinical practice consultations they receive over 10 years in an electronic Case Report Form (e-CRF). Variables retrieved will include clinical, diagnostic, treatment, eradication confirmation and outcome data. The database will allow researchers to perform specific subanalysis after approval by the Scientific Committee of the study.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Infected adult patients by Helicobacter pylori
Disqualifiers
None
Trial population
Infected adult patients by Helicobacter pylori
Trial design
Case-only
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Prescribed treatment for H. pylori
* Drugs * Dosage and intakes * Length of treatment
Secondary outcomes
Adverse Events
* Type, intensity, duration and relation with treatment * Treatment withdrawal due to adverse event
Efficacy of treatment
Eradication (yes/no), test used and date
Anonymised patient identifiers
* Country/Centre/Investigator * Autonumeric Patient identifier number * Gender * Date of Birth * Ethnic Background
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Javier P. Gisbert
Lead sponsor
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Sponsor institution