The main objective of this study is to assess the feasibility of population-based H. pylori
test-and-treat strategy for gastric cancer prevention in Europe. The study will allow to
assess the feasibility of implementing H. pylori test-and-treat program in an early 30's age
group at the population level, which will be carried out for the first time in Europe. This
will come with scientifically valid assessment of programme processes, acceptance,
effectiveness and possible adverse consequences.
The assessment of predefined quality indicators and achievements of each project task will
consequently allow us to scale up the project to the national level, for example, by
instituting a national program for gastric cancer prevention with population-based H. pylori
test-and-treat program in the asymptomatic population around 30 years of age in different EU
countries. The implementation of this strategy as a national program could result in
significantly reduced gastric cancer incidence, disease burden and costs of other H.
pylori-related diseases in the medium and long term in Slovenia and other participating
countries, thus serving as a model for the implementation of this strategy in Europe.
The results of the study can help to guide other EU countries with intermediate and high
gastric cancer incidence when implementing similar strategies. The results can also help to
guide EU countries with low gastric cancer incidence when implementing similar programs for
their subpopulations at risk (e.g. family members of patients with gastric cancer and
immigrants from countries with high H. pylori infection and gastric cancer incidence). If
implemented in a young adult population, the program can prevent further spread of H. pylori
infection by curing the infection before or when they have just started their own families,
therefore reducing the risk of intrafamilial transmission.
As shown in previously published economic evaluations of the strategy, the program is not
only cost-effective in gastric cancer prevention but also in other high-risk areas. Besides
that, H. pylori eradication will also prevent other serious clinical complications, such as
peptic ulcers, dyspepsia, primary immune thrombocytopenia and anaemia caused by H. pylori
infection.
In total, seven research centers from different European countries participate in the study -
Croatia, Ireland, Latvia, Poland, Romania, and Slovenia. A predefined population of young
people between 30 to 34 years of age will be invited to participate in the study. Based on
signed informed consent they will be offered testing for H. pylori infection.
Acceptability and participation rate of the H. pylori test-and-treat strategy, the prevalence
of H. pylori infection in the population of young adults, compliance with the 14-days
treatment scheme, the eradication rate, and any adverse effects of the treatment in the
population will be thoroughly assessed. Testing and treatment procedure will be substantiated
with data about early childhood risk factors for H. pylori infection and the use of tobacco
and alcohol consumption. Method used for capturing the participants' self-reported data will
be a questionnaire administered by a health professional or self-administered by the patient.
Each center has its own specific research design:
Clinical Hospital Center Rijeka (KBC Rijeka), Croatia: 13C-urea breath test (UBT)
confirmatory testing combined with H. pylori serology will be determined. H. pylori
positive patients will be treated by bismuth-based quadruple therapy (Protocol I):
• Protocol I with penicillin includes the following medications: 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.
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 (Protocol
II):
• Protocol II includes the following medications: 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. All medications included in Protocol I
or Protocol II will be taken orally for 14 consecutive days. After Protocol II is
completed, the remaining patients with persisting infection will be treated by
gastroenterologist according clinical practice guidelines.
University Hospital Centre Zagreb (KBC Zagreb), Croatia: 13C-urea breath test (UBT)
confirmatory testing will be determined. In case of positive results participants will
be treated with bismuth-based quadruple therapy (Protocol I). One month following the
treatment a control UBT will be performed in order to confirm eradication. In case of
treatment failure participants will be treated with second-line treatment (Protocol II).
Beacon Hospital, Ireland: H. pylori serology with high sensitivity will be offered to
participants. For participants with positive serology test results, an additional UBT
confirmatory testing will be the second step to confirm an active infection. H. pylori
positive patients will be treated by bismuth-based quadruple therapy (Protocol I). One
month after conclusion of the treatment a control UBT will be used to confirm
eradication. Patients with treatment failure will be treated with an additional second
protocol (Protocol II) according to local recommendations.
University of Latvia, Latvia: participants will be tested for H. pylori infection by
UBT. H. pylori positive participants will be offered standard triple therapy for 14 days
as the first-line therapy:
Antibiotic 1 - Amoxicillin 2 x 1000 mg, Antibiotic 2 - Clarithromycin 2 x 500 mg, Proton
pump inhibitor - Esomeprazole 2 x 40 mg.
At least 30 days after the treatment participants will be retested for H. pylori by UBT
to confirm eradication. 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
Or Pylera based:
Antibiotic 1 - Metronidazole 4 x 125 mg Antibiotic 2 - Tetracycline 4 x 125 mg Colloidal
bismuth - Bismuth Subcitrate Potassium 4 x 140 mg Proton pump inhibitor - Esomeprazole 2
x 40 mg
Uniwersytet medyczny we Wrocławiu, Poland: participants will be tested for H. pylori
infection by locally validated H. pylori serology test. In case of a positive result the
UBT will be performed for confirmation. Positive patients will be treated with
bismuth-based quadruple therapy (Protocol I) followed by control UBT in order to confirm
eradication. Treatment failure participants will be treated with second line treatment
(Protocol II).
Iuliu Hațieganu University of Medicine and Pharmacy (UMF), Romania: Locally validated H.
pylori serology with high sensitivity will be offered to participants. For participants
with positive serology test results, additional UBT confirmatory testing will be the
second step to confirm an active infection. H. pylori positive patients with be treated
by bismuth-based quadruple therapy (Protocol I). One month after conclusion of the
treatment a control UBT will be used to confirm eradication. Patients with treatment
failure will be treated with additional second protocol (Protocol II) according to local
recommendations.
National Institute of Public Health (NIJZ), Slovenia: Locally validated H. pylori
serology with high sensitivity will be offered to participants. For participants with
positive serology test results, additional UBT confirmatory testing will be the second
step to confirm an active infection. H. pylori positive patients with be treated by
bismuth-based quadruple therapy (Protocol I). One month after the conclusion of the
treatment a control UBT will be used to confirm eradication. Patients with treatment
failure will be treated with an additional second protocol (Protocol II) according to
local recommendations.
The study will be conducted, commencing in 2024 and concluding in 2026. This timeframe has
been chosen to allow for participant recruitment, conducting the study and data analysis for
a thorough assessment of the feasibility of the proposed screening strategy.