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

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

Interventions

DRUG

Bismuth Subcitrate

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.

DRUG

Esomeprazole

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.

DRUG

Metronidazole

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.

DRUG

Amoxicillin

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.

DRUG

Clarithromycin

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.

DRUG

Levofloxacin

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.

Sponsors & Collaborators

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

  collaborator OTHER

• National Institute of Public Health, Slovenia

  lead OTHER_GOV

Principal Investigators

• Bojan Tepeš, PhD · NIJZ

• Jernej Završnik, PhD · Community Healthcare Center dr. Adolf Drolc Maribor (HCM)

Eligibility

Min Age

30 Years

Max Age

34 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-02-01

Primary Completion

2024-12-31

Completion

2025-01-31

Countries

• Slovenia

Study Locations