Eradication of Helicobacter Pylori in Adolescents in Chile
A Randomized "Screen and Treat" Helicobacter Pylori Eradication Trial in 14-18 Years Old Adolescents Residing in Three Regions of Chile: Effectiveness and Microbiological-host Implications
This study is testing a new approach to treat Helicobacter pylori infections in healthy teenagers in Chile to see if it can help prevent future health problems like stomach cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 500 (estimated) |
| Ages | 14 Years to 18 Years |
| Sex | All |
| Sponsor | University of Chile Academic / other |
| Locations | 3 sites (Coyhaique and 2 other locations) |
| Trial ID | NCT05926804 on ClinicalTrials.gov |
What this trial studies
This trial aims to evaluate the effectiveness of a 'screen and treat' strategy for Helicobacter pylori eradication in healthy adolescents aged 14-18 in three regions of Chile. The study will involve administering a combination of antibiotics and a proton pump inhibitor to participants with confirmed H. pylori infection. The primary focus is on assessing the clinical and molecular benefits of eradication therapy, as well as monitoring any potential microbial side effects. The trial builds on previous findings that indicate high success rates of eradication in younger populations and aims to improve long-term health outcomes related to gastric cancer.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy teenagers aged 14-18 from Colina, Temuco, or Coyhaique with persistent H. pylori infection.
Not a fit: Patients with known allergies to the trial medications or those exhibiting signs of organic abdominal pain may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of gastric cancer in adolescents by effectively eradicating H. pylori infections early.
How similar studies have performed: Previous studies have shown high success rates in H. pylori eradication among children, supporting the feasibility of this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Coyhaique and 2 other locations
- Universidad de Aysén — Coyhaique, Chile (Recruiting)
- Universidad de Chile — Santiago, Chile (Recruiting)
- Universidad de la Frontera — Temuco, Chile (Recruiting)
Study contacts
- Principal investigator: Miguel O'Ryan, MD — University of Chile
- Study coordinator: Yalda Lucero, MD, PhD
- Email: ylucero@uchile.cl
- Phone: +56229786658
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.