H. Pylori Screen-and-treat Study in a Population of Young Adults

NCT06275204 | Recruiting DMC

• 1 other identifier: 101101252
• Study Type: observational
• Target: 6,800
• Locations: 6 countries
• Sites: 7

Brief Summary

Gastric cancer remains a major challenge to public health on a global scale. H. pylori related cancer burden contributes to the largest proportion of cancer cases attributable to infections in Europe. Considering its absolute burden and persisting disparities, in addition to the substantial prevalence of H. pylori infection worldwide that is treatable, gastric cancer is a logical target for urgent action for prevention. Population-based H. pylori test-and-treat has therefore been proposed as a strategy for gastric cancer prevention. To fill the gaps in knowledge about gastric cancer prevention through H. pylori screening and eradication in younger adults, a study of a population-based H. pylori test-and-treat strategy in Ireland, Croatia, Latvia, Poland, Romania and Slovenia. Main goals of this study are to assess future program processes, feasibility, acceptability and effectiveness. In total of 6,800 adults aged 30-34 will be tested for H. pylori infection. They will be randomly selected to represent the chosen population and invited to participate in the study based on informed consent. Confirmed infections will be treated by available combined therapy in line with treatment guidelines and the success of eradication will be retested during a control check-up. Patients who will provide their consent to participate will undertake an interview about the risk factors in early childhood and their habits regarding alcohol consumption and use of tobacco. Compliance to testing and treatment, treatment results, adverse effects and reasons for dropping out will be additionally monitored. Gathered data will be analysed in alignment with our research questions. The investigators will disseminate reports and present the results to both the general public and the scientific community in order to foster future developments in gastric cancer prevention.

Conditions

Gastric Cancer; H Pylori Infection; H Pylori Eradication; H-pylori

Keywords

H. pylori; gastric cancer; eradication therapy; screening

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.

  1 year

Secondary Outcomes (3)

• Eradication rate of infection with H. pylori

  1 year

• Description of the adverse events profile

  1 year

• Participation rate of subjects selected for the program

  1 year

Study Arms (4)

Protocol I

H. pylori positive patients who will be treated by bismuth-based quadruple therapy. Participating centers: KBC Rijeka, Croatia; KBC Zagreb, Croatia; Beacon Hospital, Ireland; Uniwersytet medyczny we Wrocławiu, Poland; UMF Cluj-Napoca, Romania; NIJZ, Slovenia

Drug: Bismuth-based quadruple therapy

Protocol II

In case there will be a treatment failure after bismuth-based quadruple therapy, the remaining patients with a positive infection will be referred to a levofloxacin based quadruple therapy. Participating centers: KBC Rijeka, Croatia; KBC Zagreb, Croatia; Beacon Hospital, Ireland; Uniwersytet medyczny we Wrocławiu, Poland; UMF Cluj-Napoca, Romania; NIJZ, Slovenia

Drug: Levofloxacin-based quadruple therapy

Standard triple therapy

H. pylori positive participants who will offered standard triple therapy. Participating center: University of Latvia, Latvia

Drug: Standard triple therapy

Second line treatment - levofloxacin-based

In case there will be a treatment failure after standart triple therapy, the remaining patients with a positive infection will be referred to a second line treatment Participating center: University of Latvia, Latvia

Drug: Levofloxacin-based triple

Interventions

Bismuth-based quadruple therapy DRUG

Participants who are positive with H. pylori will receive bismuth-based quadruple therapy: Antibiotic 1 - Amoxicillin 4 x 500 mg or Clarithromycin 2 x 400 mg, Antibiotic 2 - Metronidazole 4 x 400 mg, Proton pump inhibitor - Esomeprazole 2 x 40 mg, Colloidal bismuth - Bismuth oxide 4 x 120 mg.

Protocol I

Levofloxacin-based quadruple therapy DRUG

In case there will be a treatment failure after Protocol I is completed, the remaining patients with a positive infection will be referred to a secondary treatment: Antibiotic 1 - Levofloxacin 1 x 500 mg, Antibiotic 2 - Metronidazole 4 x 400 mg, Proton pump inhibitor - Esomeprazole 2 x 40 mg, Colloidal bismuth - Bismuth oxide 4 x 120 mg.

Protocol II

Standard triple therapy DRUG

Participants who are positive for H. pylori will receive a standard triple therapy: Antibiotic 1 - Amoxicillin 2 x 1000 mg, Antibiotic 2 - Clarithromycin 2 x 500 mg, Proton pump inhibitor - Esomeprazole 2 x 40 mg.

Standard triple therapy

Levofloxacin-based triple DRUG

Participants with treatment failure will be recommended second line treatment - levofloxacin-based: Antibiotic 1 - Levofloxacin 2 x 500 mg, Antibiotic 2 - Amoxicillin 2 x 1000 mg, Proton pump inhibitor - Esomeprazole 2 x 40 mg

Second line treatment - levofloxacin-based

Eligibility Criteria

• Age: 30 Years - 34 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Infected adult patients by Helicobacter pylori

You may qualify if:

• Young adults (generally 30 - 34 years of age)

You may not qualify if:

• Patients with mental or developmental limitations who cannot provide a fully-informed consent to participate (based on the assessment from research or patient's personal physician team)
• Previously treated H. pylori infection
• History of partial or total gastric resection due to benign or malign lesions

Sponsors & Collaborators

• University of Latvia: lead
• Clinical Hospital Center Rijeka: collaborator
• Clinical Hospital Centre Zagreb: collaborator
• Beacon Hospital: collaborator
• Wroclaw Medical University: collaborator
• Iuliu Hatieganu University of Medicine and Pharmacy: collaborator
• National Institute of Public Health, Slovenia: collaborator

Study Sites (7)

University Hospital Centre Zagreb

Zagreb, City of Zagreb, 10000, Croatia

RECRUITING

Clinical Hospital Center Rijeka

Rijeka, 51000, Croatia

RECRUITING

Beacon Hospital

Dublin, D18 AK68, Ireland

RECRUITING

Clinical and Preventive Medicine of the University of Latvia

Riga, LV1079, Latvia

NOT YET RECRUITING

Wroclaw Medical University

Wroclaw, 50-367, Poland

RECRUITING

Iuliu Hatieganu University of Medicine and Pharmacy

Cluj-Napoca, Cluj, 400003, Romania

RECRUITING

National Institute of Public Health, Slovenia

Ljubljana, 1000, Slovenia

RECRUITING

Related Links

• Related Info

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Central Study Contacts

Principal Investigator of the Study - Bojan Tepeš (National Institute of Public Health, Slovenia), Prof., MD

CONTACT

0038641325916; bojan.tepes@siol.net

Tatjana Kofol Bric (National Institute of Public Health, Slovenia), MD

CONTACT

0038612441484; Tatjana.Kofol@nijz.si

Study Design

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

Study Record Dates

• First Submitted: February 8, 2024
• First Posted: February 23, 2024
• Study Start: March 4, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 5, 2024

Record last verified: 2024-03

Locations

RO (1); CR (2); IE (1); SL (1); LA (1); PL (1)