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

ConditionsGastric Cancer H Pylori Infection H Pylori Eradication H-pylori

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age30-34

SponsorUniversity of Latvia

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Young adults (generally 30 - 34 years of age)

Disqualifiers

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

Trial population

Infected adult patients by Helicobacter pylori

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

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.
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.
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.
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

Treatment groups

6,800 Participants

are divided into 4 treatment groups

Group A: Protocol I1 intervention

Group B: Protocol II1 intervention

Group C: Standard triple therapy1 intervention

Group D: Second line treatment - levofloxacin-based1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

1 year

Secondary outcomes

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 quadruple therapy regimen.

Time frame

1 year

Description of the adverse events profile

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

Time frame

1 year

Participation rate of subjects selected for the program

a) completion of the enrollment process (points a)-d)); b) completion of the prospective study (points e)-h)). 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 (%).

Time frame

1 year