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Helicobacter Pylori InfectionNCT06216639

Feasibility Study of the Proposed Test-and-treat Screening Program in Younger Participants With H. Pylori Infection

An observational study of Helicobacter Pylori Infection, run by National Institute of Public Health, Slovenia at 1 site in Slovenia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 30 to 34 years
Conditions the study is for
Helicobacter Pylori Infection
What is being tested?
Bismuth Subcitrate, Esomeprazole and Metronidazole
Type of treatment
Pill or oral medicine
How many people
2,000 participants
Where
1 siteSlovenia
Study dates
1 Feb 2024to Jan 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 34 years
  • All sexes
  • No healthy volunteers
  • Adult

Study population: The primary pool of potential participants is composed of younger individuals of both sexes between 30 and 34 years of age with a registered chosen personal physician at HCM. A single non-interventional cohort of 4,000 individuals will be randomly selected using Monte-Carlo sampling method. All selected individuals in a sample will be invited to participate. If the individual expresses interest in participating, the primary care team staff will decide whether or not to enroll the individual in the study based on the inclusion and exclusion criteria.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Slovenia1 site

  • Community Healthcare Center dr. Adolf Drolc Maribor (HCM)

    Maribor, 2000

Other trials in Slovenia

About this study

Official title: 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

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.

Read the detailed description

Gastric cancer remains an important public health issue due to its high incidence rate and relatively low five-year survival rate. H. pylori infection has been found to be the main cause of gastric cancer and is responsible for 89% of non-cardia gastric cancers. There is also evidence that H. pylori eradication significantly reduces the incidence and mortality due to gastric cancer. According to the proposal based on available data, the population-based test-and-treat screening program may be the best available evidence-based intervention to prevent the occurrence of gastric cancer. In its recommendations from September 9th 2023, the European Council also supported the implementation of a screening program particularly in European regions with an increased prevalence of H. pylori and incidence of gastric cancer. The aim of this study is to scientifically evaluate the feasibility, acceptability and effectiveness of the proposed population-based test-and-treat strategy for the eradication of H. pylori infection.

The proposed test-and-treat strategy is targeted at the population around the age of 30 years who are infected with H. pylori and predominantly asymptomatic. The main questions it aims to answer are:

  • Is the proposed population-based H. pylori test-and-treat strategy feasible and acceptable in a community health service setting?
  • Is the proposed population-based H. pylori test-and-treat strategy effective in a community health service setting?
  • What is the profile of adverse events in the treated participants?

Participants will be randomly selected from the population pool of individuals aged 30-34 years who have a chosen personal physician at Community Healthcare Center dr. Adolf Drolc Maribor (HCM). Enrolled participants who will give their informed consent will be interviewed by a registered nurse regarding risk factors for developing H. pylori infection and selected lifestyle habits. In addition, serology testing for the presence of H. pylori antibodies will be performed on all participants. Participants with a positive serology result will be given a confirmatory urea breath test (UBT). Those participants with a confirmed active H. pylori infection will be treated with bismuth-based quadruple therapy, and the success of eradication will then be verified by UBT one month after the treatment. Participants with a positive result of the second UBT will be treated again with a second-line modified bismuth-based quadruple therapy, and the success of eradication will be verified by UBT. Compliance with testing and treatment, treatment outcomes, adverse events and reasons for withdrawing participation will be monitored for each of the participants. The feasibility and sustainability of the proposed test-and-treat strategy will be evaluated using several key performance indicators that follow the structure of five principal areas of feasibility. Data will be entered into the REDCap online survey application and analyzed using IBM SPSS Statistics software.

The results of this study will enable to potentially scale up the project to the national level and present a potential model for the implementation of this strategy in Europe. Second, the results will contribute to the implementation of the Europe's Beating Cancer Plan goal of preventing gastric cancers caused by H. pylori infections. Finally, this study will provide additional real-world data for the preparation of Expert Working Group Report of the International Agency for Research on Cancer of the World Health Organization (IARC/WHO), which will include a minimum set of standards for the implementation of a population-based screening program at the international level.

Being tested
Bismuth Subcitrate, Esomeprazole, Metronidazole, Amoxicillin, Clarithromycin
Keywords
Helicobacter Pylori, Stomach Neoplasms, Mass Screening, Preventive Health Services, Feasibility Studies, Screening Acceptability, Treatment Outcome, Test-and-treat Strategy, Drug-Related Side Effects and Adverse Reactions
Medical subject headings
Stomach Neoplasms, Drug-Related Side Effects and Adverse Reactions

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bismuth SubcitrateDrug

    Also called Bizmutov oksid Krka 120 mg filmsko obložene tablete

    Tripotassium dicitratobismuthate 120 mg film-coated tablets. Prescribed for both primary and (potential) secondary treatment with bismuth-based quadruple therapy in participants with active H. pylori infection. The prescribed daily dose is 120 mg QID for a period of 14 days.

  • EsomeprazoleDrug

    Also called Emozul 40 mg trde gastrorezistentne kapsule, Nexium 40 mg gastrorezistentne tablete, Nillar 40 mg gastrorezistentne tablete

    Esomeprazol 40 mg gastro-resistant tablets or hard capsules. Which one of the three brands is prescribed for an individual participant in this prospective study depends on the decision of a chosen personal physician. Prescribed for both primary and (potential) secondary treatment with bismuth-based quadruple therapy in participants with active H. pylori infection. The prescribed daily dose is 40 mg BID for a period of 14 days.

  • MetronidazoleDrug

    Also called Efloran 400 mg tablete

    Metronidazol 400 mg tablets. Prescribed for both primary and (potential) secondary treatment with bismuth-based quadruple therapy in participants with active H. pylori infection. The prescribed daily dose is 400 mg QID for a period of 14 days.

  • AmoxicillinDrug

    Also called Amoksicilin Belupo 500 mg disperzibilne tablete, Hiconcil 500 mg trde kapsule

    Amoxicillin 500 mg dispersible tablets or hard capsules. Which one of the two brands is prescribed for an individual participant in this prospective study depends on the decision of a chosen personal physician. Prescribed only for the primary treatment with bismuth-based quadruple therapy in participants with active H. pylori infection who are not allergic to penicillin. The prescribed daily dose is 500 mg QID for a period of 14 days.

  • ClarithromycinDrug

    Also called Fromilid 500 mg filmsko obložene tablete

    Clarithromycin 500 mg film-coated tablets. Prescribed only for the primary treatment with bismuth-based quadruple therapy in participants with active H. pylori infection who are allergic to penicillin. The prescribed daily dose is 500 mg BID for a period of 14 days.

  • LevofloxacinDrug

    Also called Tavanic 500 mg filmsko obložene tablete

    Levofloxacin 500 mg film-coated tablets. Prescribed only for the (potential) secondary treatment with bismuth-based quadruple therapy in participants with active H. pylori infection. The prescribed daily dose is 500 mg OID for a period of 14 days.

Study groups in NCT06216639
Study groupRoleWhat they receive
Individuals between 30 and 34 years of age registered at HCMRandom sample of participants representing the eligible cohort is drawn.
Receives: Drug: Bismuth Subcitrate; Drug: Esomeprazole; Drug: Metronidazole; Drug: Amoxicillin; Drug: Clarithromycin; Drug: Levofloxacin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Healthcare workers' assessment of feasibility and acceptability of the proposed practical implementation of a screening program

    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.

    Measured: 1 year after the completion of prospective study.

Secondary outcomes (3)

  1. Participation rate of subjects selected for the program

    Subtraction of 1) study participants who:

    1. did not respond to an invitation,
    2. signed the informed consent form but were not included in the study due to exclusion criteria,
    3. declined to take a serology test,
    4. declined to take any of the UBTs as specified in the study protocol,
    5. had their therapy postponed due to maternity reasons,
    6. declined to be re-treated after the treatment failure of primary therapy,
    7. voluntarily withdrew at any time during their participation in the study,
    8. withdrew from the study within points a)-g) combined, from 2) all participants invited in the study.

    The participation rate is measured in frequencies and percentage points (%).

    Measured: 3 months after: a) completion of the enrollment process (points a)-d)); b) completion of the prospective study (points e)-h)).

  2. Eradication rate of infection with H. pylori

    Subtraction of 1) participants who were subjected to treatment failure of the primary therapy regimen from 2) all participants with an active H. pylori infection who underwent the primary bismuth-based quadruple therapy regimen.

    The eradication rate is measured in frequencies and percentage points (%).

    Measured: 3 months after enrollment of the last participant who took a control UBT after the completion of primary bismuth-based quadruple therapy regimen.

  3. Description of the adverse events profile

    Qualitative records of all self-reported (or physician-reported) adverse events during and after primary (or secondary) bismuth-based quadruple therapy regimen. All non-serious or serious adverse event will be reported.

    Measured: 6 months after enrollment of the last participant who took a second control UBT after the completion of secondary bismuth-based quadruple therapy regimen.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jan 2024
  2. Study start1 Feb 2024
  3. Primary completionDec 2024 (estimated)
  4. Study completionJan 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
2,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06216639
Sponsor's protocol ID
EUROHELICAN01
Status last verified
Feb 2024
First submitted
5 Jan 2024
Last updated
9 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bowen 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.

    PubMed 19362699

  • Chiang 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.

    PubMed 32792335

  • de 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.

    PubMed 31862245

  • Ford 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.

    PubMed 32205420

  • Kowada 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.

    PubMed 36565366

  • Lansdorp-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.

    PubMed 24182612

  • Lee 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.

    PubMed 26696028

  • Lee YC, Chiang TH, Chou CK, Tu YK, Liao WC, Wu MS, Graham DY. Association Between Helicobacter pylori Eradication and Gastric Cancer Incidence: A Systematic Review and Meta-analysis. Gastroenterology. 2016 May;150(5):1113-1124.e5. doi: 10.1053/j.gastro.2016.01.028. Epub 2016 Feb 2.

    PubMed 26836587

  • Liou JM, Malfertheiner P, Lee YC, Sheu BS, Sugano K, Cheng HC, Yeoh KG, Hsu PI, Goh KL, Mahachai V, Gotoda T, Chang WL, Chen MJ, Chiang TH, Chen CC, Wu CY, Leow AH, Wu JY, Wu DC, Hong TC, Lu H, Yamaoka Y, Megraud F, Chan FKL, Sung JJ, Lin JT, Graham DY, Wu MS, El-Omar EM; Asian Pacific Alliance on Helicobacter and Microbiota (APAHAM). Screening and eradication of Helicobacter pylori for gastric cancer prevention: the Taipei global consensus. Gut. 2020 Dec;69(12):2093-2112. doi: 10.1136/gutjnl-2020-322368. Epub 2020 Oct 1.

    PubMed 33004546

  • Malfertheiner P, Megraud F, O'Morain CA, Gisbert JP, Kuipers EJ, Axon AT, Bazzoli F, Gasbarrini A, Atherton J, Graham DY, Hunt R, Moayyedi P, Rokkas T, Rugge M, Selgrad M, Suerbaum S, Sugano K, El-Omar EM; European Helicobacter and Microbiota Study Group and Consensus panel. Management of Helicobacter pylori infection-the Maastricht V/Florence Consensus Report. Gut. 2017 Jan;66(1):6-30. doi: 10.1136/gutjnl-2016-312288. Epub 2016 Oct 5.

    PubMed 27707777

  • Malfertheiner P, Megraud F, Rokkas T, Gisbert JP, Liou JM, Schulz C, Gasbarrini A, Hunt RH, Leja M, O'Morain C, Rugge M, Suerbaum S, Tilg H, Sugano K, El-Omar EM; European Helicobacter and Microbiota Study group. Management of Helicobacter pylori infection: the Maastricht VI/Florence consensus report. Gut. 2022 Aug 11;71(9):1724-1762. doi: 10.1136/gutjnl-2022-327745.

    PubMed 35944925

  • Ozeki K, Asano M, Furuta T, Ojima T. Relationship between primary eradication of Helicobacter pylori and drinking habits in women: collaborative research between a pharmacy and a clinic. Epidemiol Infect. 2019 Oct 22;147:e292. doi: 10.1017/S0950268819001730.

    PubMed 31637982

  • Park JY, Herrero R. Recent progress in gastric cancer prevention. Best Pract Res Clin Gastroenterol. 2021 Mar-Apr;50-51:101733. doi: 10.1016/j.bpg.2021.101733. Epub 2021 Feb 18.

    PubMed 33975687

  • Sarmasti M, Khoshbaten M, Khalili F, Yousefi M. Cost-Effectiveness of Screening Helicobacter pylori for Gastric Cancer Prevention: a Systematic Review. J Gastrointest Cancer. 2022 Dec;53(4):1093-1103. doi: 10.1007/s12029-021-00726-7. Epub 2021 Oct 25.

    PubMed 34694594

  • Sekhon M, Cartwright M, Francis JJ. Acceptability of healthcare interventions: an overview of reviews and development of a theoretical framework. BMC Health Serv Res. 2017 Jan 26;17(1):88. doi: 10.1186/s12913-017-2031-8.

    PubMed 28126032

Questions about this trial

What is this clinical trial studying?

An observational study of Helicobacter Pylori Infection, run by National Institute of Public Health, Slovenia at 1 site in Slovenia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 9 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Healthcare workers' assessment of feasibility and acceptability of the proposed practical implementation of a screening program (time frame: 1 year after the completion of prospective study.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06216639, which also lists 18 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2024.

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