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

RecruitingNAAges 14 Years - 18 YearsAllMiguel O'Ryan Gallardo
NCT05926804 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 constitutes the main cause of GC worldwide. A long-term process occurs from premalignant lesions to carcinoma. H. pylori eradication during early stages of disease significantly impacts outcomes, favoring survival, disease reversal and molecular changes, which supports a "screen and treat" strategy in asymptomatic populations in areas with intermediate-to-high GC prevalence. The Investigators' previous research has shown that H. pylori infection is acquired in early childhood with low rates of spontaneous eradication. A pilot treatment study in a subset of school-aged asymptomatic children showed a high rate of successful eradication (\>95%), good tolerance, and was associated with a decrease i

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📋 Eligibility rules (as published)
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
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What it tests

  • Lansoprazole
  • Amoxicillin
  • Clarithromycin
  • Metronidazole
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Where

3 sites
Universidad de Aysén
Coyhaique, Chile
Universidad de Chile
Santiago, Chile
Universidad de la Frontera
Temuco, Chile
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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