Actively Recruiting
Multicentric Transnational H. Pylori Screen-and-treat Study in a Population of Young Adults
Led by University of Latvia · Updated on 2024-03-05
6800
Participants Needed
7
Research Sites
8 weeks
Total Duration
On this page
Sponsors
U
University of Latvia
Lead Sponsor
C
Clinical Hospital Center Rijeka
Collaborating Sponsor
AI-Summary
What this Trial Is About
Gastric cancer is a significant public health challenge globally, with a major portion of cases in Europe linked to Helicobacter pylori infection. This research aims to evaluate a population-based H. pylori test-and-treat strategy to prevent gastric cancer in young adults aged 30 to 34 across several European countries. The study focuses on assessing the program's processes, feasibility, acceptance, and effectiveness in reducing infection and related cancer risks. Participants who test positive for H. pylori will receive treatment according to local protocols, including a 14-day course of either bismuth-based quadruple therapy or standard triple therapy. If the first treatment fails, a secondary treatment with levofloxacin-based therapy will be offered. The study is conducted in seven centers across Croatia, Ireland, Latvia, Poland, Romania, and Slovenia, each following specific testing and treatment procedures. During the study, participants will be interviewed about early childhood risk factors and habits such as alcohol and tobacco use. Researchers will monitor treatment adherence, infection eradication success, adverse effects, and reasons for dropping out. The study duration extends from 2024 to 2026, allowing for recruitment, treatment, retesting, and thorough data analysis to inform future gastric cancer prevention strategies in Europe.
CONDITIONS
Brief Title
H. Pylori Screen-and-treat Study in a Population of Young Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Young adults generally between 30 and 34 years of age
You will not qualify if you...
- Individuals with mental or developmental limitations who cannot give fully informed consent
- People previously treated for H. pylori infection
- History of partial or total stomach surgery due to benign or malignant conditions
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for H. pylori testing and consent
Duration - 14 consecutive days per treatment course
Participants who test positive for H. pylori will receive one of several antibiotic treatment regimens lasting 14 days, depending on the study center. Treatment includes bismuth-based quadruple therapy, standard triple therapy, or levofloxacin-based therapies.
1 to 2 visits depending on treatment response and center-specific protocol
Duration - Approximately 1 month post-treatment
Participants will be retested approximately one month after treatment completion to confirm eradication of H. pylori infection. Additional treatment may be offered if infection persists.
1 follow-up visit for eradication testing
Trial Site Locations
Total: 7 locations
1
University Hospital Centre Zagreb
Zagreb, City of Zagreb, Croatia, 10000
Actively Recruiting
2
Clinical Hospital Center Rijeka
Rijeka, Croatia, 51000
Actively Recruiting
3
Beacon Hospital
Dublin, Ireland, D18 AK68
Actively Recruiting
4
Clinical and Preventive Medicine of the University of Latvia
Riga, Latvia, LV1079
Not Yet Recruiting
5
Wroclaw Medical University
Wroclaw, Poland, 50-367
Actively Recruiting
6
Iuliu Hatieganu University of Medicine and Pharmacy
Cluj-Napoca, Cluj, Romania, 400003
Actively Recruiting
7
National Institute of Public Health, Slovenia
Ljubljana, Slovenia, 1000
Actively Recruiting
Research Team
P
Principal Investigator of the Study - Bojan Tepeš (National Institute of Public Health, Slovenia), Prof., MD
T
Tatjana Kofol Bric (National Institute of Public Health, Slovenia), MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
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