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European Registry on the Management of Helicobacter Pylori Infection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02328131
Recruitment Status : Recruiting
First Posted : December 31, 2014
Last Update Posted : March 1, 2023
Sponsor:
Information provided by (Responsible Party):
Javier P. Gisbert, Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

Study Description
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Brief Summary:

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.


Condition or disease
H. Pylori Infection

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Study Design
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Study Type : Observational
Estimated Enrollment : 10000 participants
Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Prescribed treatment for H. pylori [ Time Frame: 1 year ]
    • Drugs
    • Dosage and intakes
    • Length of treatment


Secondary Outcome Measures :
  1. Adverse Events [ Time Frame: 1 year ]
    • Type, intensity, duration and relation with treatment
    • Treatment withdrawal due to adverse event

  2. Efficacy of treatment [ Time Frame: 1 year ]
    Eradication (yes/no), test used and date

  3. Anonymised patient identifiers [ Time Frame: 1 year ]
    • Country/Centre/Investigator
    • Autonumeric Patient identifier number
    • Gender
    • Date of Birth
    • Ethnic Background


Eligibility Criteria
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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
Study Population
Infected adult patients by Helicobacter pylori
Criteria

Inclusion Criteria:

  • Infected adult patients by Helicobacter pylori

Exclusion Criteria:

Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Javier Pérez Gisbert, MD +34 913093911 javier.p.gisbert@gmail.com

Locations
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Sponsors and Collaborators
Javier P. Gisbert
Investigators
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Principal Investigator: Javier Pérez Gisbert, MD Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Nyssen OP, Vaira D, Perez Aisa A, Rodrigo L, Castro-Fernandez M, Jonaitis L, Tepes B, Vologzhanina L, Caldas M, Lanas A, Lucendo AJ, Bujanda L, Ortuno J, Barrio J, Huguet JM, Voynovan I, Lasala JP, Sarsenbaeva AS, Fernandez-Salazar L, Molina-Infante J, Jurecic NB, Areia M, Gasbarrini A, Kupcinskas J, Bordin D, Marcos-Pinto R, Lerang F, Leja M, Buzas GM, Niv Y, Rokkas T, Phull P, Smith S, Shvets O, Venerito M, Milivojevic V, Simsek I, Lamy V, Bytzer P, Boyanova L, Kunovsky L, Beglinger C, Doulberis M, Marlicz W, Goldis A, Tonkic A, Capelle L, Puig I, Megraud F, Morain CO, Gisbert JP; European Registry on Helicobacter pylori Management Hp-EuReg Investigators. Empirical Second-Line Therapy in 5000 Patients of the European Registry on Helicobacter pylori Management (Hp-EuReg). Clin Gastroenterol Hepatol. 2022 Oct;20(10):2243-2257. doi: 10.1016/j.cgh.2021.12.025. Epub 2021 Dec 23.
Nyssen OP, Perez-Aisa A, Tepes B, Castro-Fernandez M, Kupcinskas J, Jonaitis L, Bujanda L, Lucendo A, Jurecic NB, Perez-Lasala J, Shvets O, Fadeenko G, Huguet JM, Kikec Z, Bordin D, Voynovan I, Leja M, Machado JC, Areia M, Fernandez-Salazar L, Rodrigo L, Alekseenko S, Barrio J, Ortuno J, Perona M, Vologzhanina L, Romero PM, Zaytsev O, Rokkas T, Georgopoulos S, Pellicano R, Buzas GM, Modolell I, Gomez Rodriguez BJ, Simsek I, Simsek C, Lafuente MR, Ilchishina T, Camarero JG, Dominguez-Cajal M, Ntouli V, Dekhnich NN, Phull P, Nunez O, Lerang F, Venerito M, Heluwaert F, Tonkic A, Caldas M, Puig I, Megraud F, O'Morain C, Gisbert JP; Hp-EuReg Investigators. Adverse Event Profile During the Treatment of Helicobacter pylori: A Real-World Experience of 22,000 Patients From the European Registry on H. pylori Management (Hp-EuReg). Am J Gastroenterol. 2021 Jun 1;116(6):1220-1229. doi: 10.14309/ajg.0000000000001246.

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Responsible Party: Javier P. Gisbert, Javier P. Gisbert MD, Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
ClinicalTrials.gov Identifier: NCT02328131    
Other Study ID Numbers: Hp-EuReg
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
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Disease Attributes
Pathologic Processes