Actively Recruiting

Age: 18Years +
All Genders
NCT02328131

European Registry on the Management of Helicobacter Pylori Infection

Led by Javier P. Gisbert · Updated on 2024-10-02

10000

Participants Needed

30

Research Sites

1121 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

European Registry on the Management of Helicobacter Pylori Infection

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Infected adult patients by Helicobacter pylori
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

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Trial Site Locations

Total: 30 locations

1

Medical University Wien

Vienna, Austria

Actively Recruiting

2

CHU de Charleroi, Charleroi

Charleroi, Belgium

Actively Recruiting

3

Medical University of Sofia

Sofia, Bulgaria

Actively Recruiting

4

University Hospital Merkur

Zagreb, Croatia

Actively Recruiting

5

Charles University Faculty of Medicine

Prague, Czechia

Actively Recruiting

6

Køge University Hospital

Køge, Denmark

Actively Recruiting

7

University of Tartu

Tartu, Estonia

Actively Recruiting

8

Herttoniemi Hospital, Helsinki

Helsinki, Finland

Actively Recruiting

9

Hôpital Pellegrin

Bordeaux, France

Actively Recruiting

10

Medizin Uni Magdeburg

Magdeburg, Germany

Actively Recruiting

11

Gastroenterology Clinic, Henry Dunant Hospital

Athens, Greece

Actively Recruiting

12

Ferencváros Health Centre, Gaastroenterology

Budapest, Hungary

Actively Recruiting

13

Adelaide Meath Hospital, Dublin

Dublin, Ireland

Actively Recruiting

14

Studio Gasbarrini

Roma, Italy

Actively Recruiting

15

Digestive Diseases Centre GASTRO

Riga, Latvia

Actively Recruiting

16

Lithuanian university of Health Sciences Hospital

Kaunas, Lithuania

Actively Recruiting

17

Ikazia Ziekenhuis/ Erasmus Medisch Centrum

Rotterdam, Netherlands

Actively Recruiting

18

Central Hospital of Ostfold

Fredrikstad, Norway

Actively Recruiting

19

Departament of Gastroenterology, Medical Centre for Postgraduate Education

Warsaw, Poland

Actively Recruiting

20

Porto

Porto, Portugal

Actively Recruiting

21

Timisoara

Timișoara, Romania

Actively Recruiting

22

Central Scientific Research Institute of Gastroenterology

Moscow, Russia

Actively Recruiting

23

Clinical Center of Serbia

Belgrade, Serbia

Actively Recruiting

24

DC Rogaska

Rogaška Slatina, Slovenia

Actively Recruiting

25

Hospital de La Princesa, Madrid

Madrid, Spain

Actively Recruiting

26

Uppsala University Hospital.

Uppsala, Sweden

Actively Recruiting

27

University Hospital Basel

Basel, Switzerland

Actively Recruiting

28

Dokuz Eylul University School of Medicine

Izmir, Turkey (Türkiye)

Actively Recruiting

29

National Medical University

Kiev, Ukraine

Actively Recruiting

30

Leeds General Infirmiry Hospital

Leeds, United Kingdom

Actively Recruiting

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Research Team

J

Javier Pérez Gisbert, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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