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

NCT06216639 | Enrolling By Invitation

• 1 other identifier: EUROHELICAN01
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief 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. 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

Helicobacter Pylori Infection

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

Outcome Measures

Primary Outcomes (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.

  1 year after the completion of prospective study.

Secondary Outcomes (3)

• Participation rate of subjects selected for the program

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

• Eradication rate of infection with H. pylori

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

• Description of the adverse events profile

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

Study Arms (1)

Individuals between 30 and 34 years of age registered at HCM

Random sample of participants representing the eligible cohort is drawn.

Drug: Bismuth Subcitrate; Drug: Esomeprazole; Drug: Metronidazole; Drug: Amoxicillin; Drug: Clarithromycin; Drug: Levofloxacin

Interventions

Bismuth Subcitrate DRUG

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.

Also known as: Bizmutov oksid Krka 120 mg filmsko obložene tablete

Individuals between 30 and 34 years of age registered at HCM

Esomeprazole DRUG

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.

Also known as: Emozul 40 mg trde gastrorezistentne kapsule, Nexium 40 mg gastrorezistentne tablete, Nillar 40 mg gastrorezistentne tablete

Individuals between 30 and 34 years of age registered at HCM

Metronidazole DRUG

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.

Also known as: Efloran 400 mg tablete

Individuals between 30 and 34 years of age registered at HCM

Amoxicillin DRUG

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.

Also known as: Amoksicilin Belupo 500 mg disperzibilne tablete, Hiconcil 500 mg trde kapsule

Individuals between 30 and 34 years of age registered at HCM

Clarithromycin DRUG

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.

Also known as: Fromilid 500 mg filmsko obložene tablete

Individuals between 30 and 34 years of age registered at HCM

Levofloxacin DRUG

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.

Also known as: Tavanic 500 mg filmsko obložene tablete

Individuals between 30 and 34 years of age registered at HCM

Eligibility Criteria

• Age: 30 Years - 34 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Public Health, Slovenia: lead
• Community Healthcare Center dr. Adolf Drolc Maribor (HCM): collaborator

Study Sites (1)

Community Healthcare Center dr. Adolf Drolc Maribor (HCM)

Maribor, 2000, Slovenia

Location

Related Publications (17)

• 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.

  PMID: 19362699 BACKGROUND

• 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.

  PMID: 32792335 BACKGROUND

• 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.

  PMID: 31862245 BACKGROUND

• 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.

  PMID: 32205420 BACKGROUND

• 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.

  PMID: 36565366 BACKGROUND

• 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.

  PMID: 24182612 BACKGROUND

• 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.

  PMID: 26696028 BACKGROUND

• 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.

  PMID: 26836587 BACKGROUND

• 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.

  PMID: 33004546 BACKGROUND

• 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.

  PMID: 27707777 BACKGROUND

• 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 8:gutjnl-2022-327745. doi: 10.1136/gutjnl-2022-327745. Online ahead of print.

  PMID: 35944925 BACKGROUND

• 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.

  PMID: 31637982 BACKGROUND

• 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.

  PMID: 33975687 BACKGROUND

• 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.

  PMID: 34694594 BACKGROUND

• 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.

  PMID: 28126032 BACKGROUND

• Tan Y, Wei Z, Liu K, Qin Y, Hui W. Lifestyle habits and gastric cancer in an East Asian population: a Mendelian randomization study. Front Oncol. 2023 Sep 4;13:1224753. doi: 10.3389/fonc.2023.1224753. eCollection 2023.

  PMID: 37731647 BACKGROUND

• Yu J, Yang P, Qin X, Li C, Lv Y, Wang X. Impact of smoking on the eradication of Helicobacter pylori. Helicobacter. 2022 Feb;27(1):e12860. doi: 10.1111/hel.12860. Epub 2021 Oct 27.

  PMID: 34708484 BACKGROUND

MeSH Terms

Conditions

Stomach Neoplasms; Drug-Related Side Effects and Adverse Reactions

Interventions

bismuth tripotassium dicitrate; Esomeprazole; Metronidazole; Amoxicillin; Clarithromycin; Levofloxacin; Ofloxacin

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Nitroimidazoles; Nitro Compounds; Imidazoles; Azoles; Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Erythromycin; Macrolides; Polyketides; Lactones; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines

Study Officials

• Bojan Tepeš, PhD

  NIJZ

  STUDY DIRECTOR

• Jernej Završnik, PhD

  Community Healthcare Center dr. Adolf Drolc Maribor (HCM)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2024
• First Posted: January 22, 2024
• Study Start: February 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: January 1, 2025
• Last Updated: February 9, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)