Trial Title:
H. Pylori Screen-and-treat Study in a Population of Young Adults
NCT ID:
NCT06275204
Condition:
Gastric Cancer
H Pylori Infection
H Pylori Eradication
H-pylori
Conditions: Official terms:
Stomach Neoplasms
Levofloxacin
Ofloxacin
Bismuth
Conditions: Keywords:
H. pylori
gastric cancer
eradication therapy
screening
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Drug
Intervention name:
Bismuth-based quadruple therapy
Description:
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.
Arm group label:
Protocol I
Intervention type:
Drug
Intervention name:
Levofloxacin-based quadruple therapy
Description:
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.
Arm group label:
Protocol II
Intervention type:
Drug
Intervention name:
Standard triple therapy
Description:
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.
Arm group label:
Standard triple therapy
Intervention type:
Drug
Intervention name:
Levofloxacin-based triple
Description:
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
Arm group label:
Second line treatment - levofloxacin-based
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.
Detailed description:
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:
1. 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.
2. 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).
3. 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.
4. 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
5. 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).
6. 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.
7. 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.
Criteria for eligibility:
Study pop:
Infected adult patients by Helicobacter pylori
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- Young adults (generally 30 - 34 years of age)
Exclusion Criteria:
- 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
Gender:
All
Minimum age:
30 Years
Maximum age:
34 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
University Hospital Centre Zagreb
Address:
City:
Zagreb
Zip:
10000
Country:
Croatia
Status:
Recruiting
Contact:
Last name:
Masa Cavlina Sevo, MD
Phone:
00385995900847
Email:
masa.cavlina@gmail.com
Contact backup:
Last name:
Mirjana Kalauz, Asst. Prof.
Phone:
0038598519088
Email:
mirjanakalauz1@gmail.com
Investigator:
Last name:
Mirjana Kalauz, Asst. Prof.
Email:
Principal Investigator
Investigator:
Last name:
Pave Markos, MD, PhD
Email:
Sub-Investigator
Investigator:
Last name:
Tihomir Bradic, MD
Email:
Sub-Investigator
Investigator:
Last name:
Masa Cavlina Sevo, MD
Email:
Sub-Investigator
Facility:
Name:
Clinical Hospital Center Rijeka
Address:
City:
Rijeka
Zip:
51000
Country:
Croatia
Status:
Recruiting
Contact:
Last name:
Sandra Milic, MD
Phone:
0038551658122
Email:
smilic05@gmail.com
Facility:
Name:
Beacon Hospital
Address:
City:
Dublin
Zip:
D18 AK68
Country:
Ireland
Status:
Recruiting
Contact:
Last name:
Charlene Deane, MB Bch BAO, MSc
Phone:
00353879114305
Email:
charlene.deane@beaconhospital.ie
Contact backup:
Last name:
Ruth Pilkington, MB BcH BAO
Phone:
0035312937521
Email:
ruth.pilkington@beaconhospital.ie
Investigator:
Last name:
Colm O Morain, MD, MB BcH BAO, FRCPI
Email:
Principal Investigator
Investigator:
Last name:
Orlaith Kelly, PHD, MB BcH
Email:
Sub-Investigator
Investigator:
Last name:
Charlene Deane, MB Bch BAO, MSc, MRCP
Email:
Sub-Investigator
Facility:
Name:
Clinical and Preventive Medicine of the University of Latvia
Address:
City:
Riga
Zip:
LV1079
Country:
Latvia
Status:
Not yet recruiting
Contact:
Last name:
Marcis Leja, MD, PhD
Phone:
371+29497500
Email:
marcis.leja@lu.lv
Investigator:
Last name:
Marcis Leja, MD, PhD
Email:
Principal Investigator
Investigator:
Last name:
Danute Razuka Ebela, MD, PhD
Email:
Sub-Investigator
Investigator:
Last name:
Linda Mezmale, MD
Email:
Sub-Investigator
Facility:
Name:
Wroclaw Medical University
Address:
City:
Wroclaw
Zip:
50-367
Country:
Poland
Status:
Recruiting
Contact:
Last name:
Katarzyna Malinowska
Phone:
00487178417 99
Email:
k.malinowska@umw.edu.pl
Contact backup:
Last name:
Elzbieta Olejnik
Phone:
00717841666
Email:
elzbieta.olejnik@umw.edu.pl
Investigator:
Last name:
Katarzyna Neubauer, MD, PhD, Assoc. Prof.
Email:
Principal Investigator
Investigator:
Last name:
Radoslaw Kempinski, MD, PhD
Email:
Sub-Investigator
Facility:
Name:
Iuliu Hatieganu University of Medicine and Pharmacy
Address:
City:
Cluj-Napoca
Zip:
400003
Country:
Romania
Status:
Recruiting
Contact:
Last name:
Dan Lucian Dumitrascu, Prof
Phone:
0040722756475
Email:
ddumitrascu@umfcluj.ro
Contact backup:
Last name:
Radu Farcas, MD, PhD student
Phone:
0040757554422
Email:
radufr@gmail.com
Investigator:
Last name:
Radu Farcas, MD, PhD student
Email:
Sub-Investigator
Facility:
Name:
National Institute of Public Health, Slovenia
Address:
City:
Ljubljana
Zip:
1000
Country:
Slovenia
Status:
Recruiting
Contact:
Last name:
Mitja Oblak, MSc
Phone:
0038612441541
Email:
Mitja.Oblak@nijz.si
Contact backup:
Last name:
Tatjana Kofol, MD
Phone:
0038612441484
Email:
Tatjana.Kofol@nijz.si
Investigator:
Last name:
Bojan Tepeš, prof., MD
Email:
Principal Investigator
Start date:
March 4, 2024
Completion date:
December 1, 2026
Lead sponsor:
Agency:
University of Latvia
Agency class:
Other
Collaborator:
Agency:
Clinical Hospital Center Rijeka
Agency class:
Other
Collaborator:
Agency:
Clinical Hospital Centre Zagreb
Agency class:
Other
Collaborator:
Agency:
Beacon Hospital
Agency class:
Other
Collaborator:
Agency:
Wroclaw Medical University
Agency class:
Other
Collaborator:
Agency:
Iuliu Hatieganu University of Medicine and Pharmacy
Agency class:
Other
Collaborator:
Agency:
National Institute of Public Health, Slovenia
Agency class:
Other
Source:
University of Latvia
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06275204
http://togas.lu.lv
