European Registry on the Management of Helicobacter Pylori Infection
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|ClinicalTrials.gov Identifier: NCT02328131|
Recruitment Status : Recruiting
First Posted : December 31, 2014
Last Update Posted : March 1, 2023
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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.
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.
- To evaluate H. pylori infection consensus and clinical guidelines implementation in different countries.
- To perform studies focused on epidemiology, efficacy and safety of the commonly used treatments to eradicate H. pylori.
- To evaluate accessibility to healthcare technologies and drugs used in the management of H. pylori infection.
- 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.
|Condition or disease|
|H. Pylori Infection|
|Study Type :||Observational|
|Estimated Enrollment :||10000 participants|
|Official Title:||European Registry on the Management of Helicobacter Pylori Infection|
|Study Start Date :||June 2013|
|Estimated Primary Completion Date :||December 2024|
|Estimated Study Completion Date :||December 2024|
- Prescribed treatment for H. pylori [ Time Frame: 1 year ]
- Dosage and intakes
- Length of treatment
- Adverse Events [ Time Frame: 1 year ]
- Type, intensity, duration and relation with treatment
- Treatment withdrawal due to adverse event
- Efficacy of treatment [ Time Frame: 1 year ]Eradication (yes/no), test used and date
- Anonymised patient identifiers [ Time Frame: 1 year ]
- Autonumeric Patient identifier number
- Date of Birth
- Ethnic Background
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
- Infected adult patients by Helicobacter pylori
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02328131
|Contact: Javier Pérez Gisbert, MD||+34 email@example.com|
|Principal Investigator:||Javier Pérez Gisbert, MD||Fundación de Investigación Biomédica - Hospital Universitario de La Princesa|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||Javier P. Gisbert, Javier P. Gisbert MD, Fundación de Investigación Biomédica - Hospital Universitario de La Princesa|
|Other Study ID Numbers:||
|First Posted:||December 31, 2014 Key Record Dates|
|Last Update Posted:||March 1, 2023|
|Last Verified:||February 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Undecided|