A "Screen and Treat" Helicobacter Pylori Eradication Trial in Adolescents in Three Regions of Chile

Launched by MIGUEL O'RYAN GALLARDO · Jun 23, 2023

Keywords

ClinConnect Summary

This clinical trial is focused on studying how to effectively eliminate Helicobacter pylori (H. pylori) infections in healthy adolescents aged 14 to 18 in three cities in Chile. H. pylori is a common bacteria that can lead to serious stomach problems, including gastric cancer, which is a major health concern in Chile. The trial aims to screen around 1,000 teenagers to identify those who are persistently infected, with the goal of treating about 200 to 250 of them. Participants will either receive treatment to eradicate the infection or will not receive treatment for comparison. Researchers hope that over 90% of those treated will successfully eliminate the infection and that this will lead to improved stomach health.

To be eligible for this trial, teenagers must be healthy, live in Colina, Temuco, or Coyhaique, and have a confirmed H. pylori infection based on specific tests. A responsible adult family member must also be available for communication. If a teenager does not want treatment, they can still participate as a control. During the trial, participants can expect to undergo screening tests, receive treatment if eligible, and have follow-up appointments to monitor their health. This study is important because it could lead to better ways to prevent serious stomach diseases in young people.

Gender

ALL

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