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:

  1. Healthy teenagers 14-18 years of age from Colina, Temuco or Coyhaique
  2. At least one responsible adult family member accessible for phone contact.
  3. Persistent H. pylori infection determined by at least 2 positive UBT tests in a 3 months period (except for Non-infected Controls)

Exclusion Criteria:

  1. Teenagers not consenting to treatment will be invited to continue as non-treated controls.
  2. Known allergy to any of the antimicrobials used in the trial protocol (except for Non-infected Controls)
  3. 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.
  4. Prior eradication therapy
  5. 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)
  6. Pregnancy
  7. Use of immunosuppressive or biologic drugs
  8. 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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Page 1 of 1 (3 locations)

1

Universidad de Aysén

Coyhaique, Chile

2

Universidad de Chile

Santiago, Chile

3

Universidad de la Frontera

Temuco, Chile