Clinical trial · Observational
Feasibility Study of the Proposed Test-and-treat Screening Program in Younger Participants With H. Pylori Infection
EU4Health Project Eurohelican: A Single-center Prospective Feasibility Study of the Proposed Test-and-treat Preventive Screening Program in Younger Slovenian Participants Aged 30-34 Years With or Without Helicobacter Pylori Infection
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This prospective non-interventional study is being conducted as part of the EU4Health project Eurohelican. The main goal of this pilot study is to evaluate the feasibility and acceptability of implementing the proposed "test-and-treat" screening program on a population-based sample. Participants will be randomly selected from a younger population registered at the primary level of care and tested for the presence of active infection with Helicobacter pylori (H. pylori). Infected participants will undergo a bismuth-based quadruple treatment with antibiotics and a proton pump inhibitor, and will be controlled for eradication success by taking the urea breath test (UBT). A number of other participant outcomes will be also measured to provide additional pro et contra argumentation for the potential future implementation of a population-based test-and-treat screening program in Slovenia. Research reports will be disseminated and results will be presented to the public and scientific community to foster future developments in gastric cancer prevention.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Helicobacter Pylori Infection | — | UNRESOLVED | — |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Amoxicillin | Drug | — | UNRESOLVED |
| Bismuth Subcitrate | Drug | — | UNRESOLVED |
| Clarithromycin | Drug | — | UNRESOLVED |
| Esomeprazole | Drug | — | UNRESOLVED |
| Levofloxacin | Drug | — | UNRESOLVED |
| Metronidazole | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Individuals between 30 and 34 years of age registered at HCM
- description
- Random sample of participants representing the eligible cohort is drawn.
- interventionNames
- Drug: Bismuth Subcitrate
- Drug: Esomeprazole
- Drug: Metronidazole
- Drug: Amoxicillin
- Drug: Clarithromycin
- Drug: Levofloxacin
Primary outcomes (1)
- measure
- Healthcare workers' assessment of feasibility and acceptability of the proposed practical implementation of a screening program
- timeFrame
- 1 year after the completion of prospective study.
- description
- Responses to qualitative questions and summary statistics from a post-enrollment questionnaire for healthcare workers involved into the implementation of the screening program. The questionnaires will be completed by up to 100 chosen personal physicians and registered nurses from HCM who participated in this prospective study. Questionnaire preparation follows the key performance indicators for assessing the five dimensions of the standardized TELOS framework of project feasibility.
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 30 Years
- Maximum age
- 34 Years
Show eligibility criteria text
Inclusion Criteria: * Individuals aged 30-34 years, * Individuals who have a chosen personal physician at HCM, * Individuals who sign an informed consent to participate, and * Individuals who do not have a congenital or acquired intellectual disability. Exclusion Criteria: * Individuals younger than 30 years or older than 34 years, * Individuals who do not have a chosen personal physician at HCM, * Individuals who do not sign informed consent for participation, * Individuals with intellectual or developmental limitations who are unable to provide a fully-informed consent to participate (based on the assessment of the patient's primary care team) * Individuals who were previously treated for H. pylori infection, and * Individuals with a history of partial of total gastric resection due to benign or malign lesions.
References
Publications (18)
- BACKGROUNDBowen DJ, Kreuter M, Spring B, Cofta-Woerpel L, Linnan L, Weiner D, Bakken S, Kaplan CP, Squiers L, Fabrizio C, Fernandez M. How we design feasibility studies. Am J Prev Med. 2009 May;36(5):452-7. doi: 10.1016/j.amepre.2009.02.002. PMID 19362699
- BACKGROUNDChiang TH, Chang WJ, Chen SL, Yen AM, Fann JC, Chiu SY, Chen YR, Chuang SL, Shieh CF, Liu CY, Chiu HM, Chiang H, Shun CT, Lin MW, Wu MS, Lin JT, Chan CC, Graham DY, Chen HH, Lee YC. Mass eradication of Helicobacter pylori to reduce gastric cancer incidence and mortality: a long-term cohort study on Matsu Islands. Gut. 2021 Feb;70(2):243-250. doi: 10.1136/gutjnl-2020-322200. Epub 2020 Aug 13. PMID 32792335
- BACKGROUNDde Martel C, Georges D, Bray F, Ferlay J, Clifford GM. Global burden of cancer attributable to infections in 2018: a worldwide incidence analysis. Lancet Glob Health. 2020 Feb;8(2):e180-e190. doi: 10.1016/S2214-109X(19)30488-7. Epub 2019 Dec 17. PMID 31862245
- BACKGROUNDFord AC, Yuan Y, Moayyedi P. Helicobacter pylori eradication therapy to prevent gastric cancer: systematic review and meta-analysis. Gut. 2020 Dec;69(12):2113-2121. doi: 10.1136/gutjnl-2020-320839. Epub 2020 Mar 23. PMID 32205420
- BACKGROUNDKowada A. A Population-Based Helicobacter pylori Eradication Strategy Is More Cost-Effective than Endoscopic Screening. Dig Dis Sci. 2023 May;68(5):1735-1746. doi: 10.1007/s10620-022-07795-z. Epub 2022 Dec 24. PMID 36565366
- BACKGROUNDLansdorp-Vogelaar I, Sharp L. Cost-effectiveness of screening and treating Helicobacter pylori for gastric cancer prevention. Best Pract Res Clin Gastroenterol. 2013 Dec;27(6):933-47. doi: 10.1016/j.bpg.2013.09.005. Epub 2013 Sep 27. PMID 24182612
- BACKGROUNDLee YC, Chiang TH, Liou JM, Chen HH, Wu MS, Graham DY. Mass Eradication of Helicobacter pylorito Prevent Gastric Cancer: Theoretical and Practical Considerations. Gut Liver. 2016 Jan;10(1):12-26. doi: 10.5009/gnl15091.