Status:
RECRUITING
A "Screen and Treat" Helicobacter Pylori Eradication Trial in Adolescents in Three Regions of Chile
Lead Sponsor:
Miguel O'Ryan Gallardo
Collaborating Sponsors:
Fondo Nacional de Desarrollo Científico y Tecnológico, Chile
Conditions:
Helicobacter Pylori Infection
Eligibility:
All Genders
14-18 years
Phase:
NA
Brief Summary
Gastric cancer remains a global health problem, and Chile has one of the highest GC mortality rates in the region. Helicobacter pylori (H. pylori) infection is ubiquitous in Chilean adults, and it con...
Detailed Description
Background: Helicobacter pylori (H. pylori) infection is the main cause of gastric cancer (GC), and long-term process occurs from premalignant lesions to carcinoma. H. pylori eradication during early ...
Eligibility Criteria
Inclusion Criteria:
- Healthy teenagers 14-18 years of age from Colina, Temuco or Coyhaique
- At least one responsible adult family member accessible for phone contact.
- Persistent H. pylori infection determined by at least 2 positive UBT tests in a 3 months period (except for Non-infected Controls)
Exclusion Criteria:
- Teenagers not consenting to treatment will be invited to continue as non-treated controls.
- Known allergy to any of the antimicrobials used in the trial protocol (except for Non-infected Controls)
- Signs/symptoms compatible with organic abdominal pain according to Rome IV criteria: persistent right upper or right lower quadrant pain, dysphagia, odynophagia, persistent vomiting, gastrointestinal blood loss, involuntary weight loss, deceleration of linear growth, delayed puberty.
- Prior eradication therapy
- Antimicrobial course received during the previous month (at least 3 days of treatment at appropriate dosing, children meeting this criteria can be included at a later stage)
- Pregnancy
- Use of immunosuppressive or biologic drugs
- Children deemed "not healthy" after review of the questionnaire by study physician
Key Trial Info
Start Date :
August 2 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2027
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT05926804
Start Date
August 2 2022
End Date
August 1 2027
Last Update
December 17 2025
Active Locations (3)
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1
Universidad de Aysén
Coyhaique, Chile
2
Universidad de Chile
Santiago, Chile
3
Universidad de la Frontera
Temuco, Chile