NCT05926804 A "Screen and Treat" Helicobacter Pylori Eradication Trial in Adolescents in Three Regions of Chile
| NCT ID | NCT05926804 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Miguel O'Ryan Gallardo |
| Condition | Helicobacter Pylori Infection |
| Study Type | INTERVENTIONAL |
| Enrollment | 500 participants |
| Start Date | 2022-08-02 |
| Primary Completion | 2026-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 500 participants in total. It began in 2022-08-02 with a primary completion date of 2026-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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 in serum biomarkers of gastric damage (pepsinogen I and II). Based on the results of these studies, the Investigators propose to advance towards the next stage of this research process: a "screen and treat" strategy. The current trial starts with a Screening phase testing up to 1000 asymptomatic adolescents 14-18 years of age from 3 cities of Chile (Colina, Temuco and Coyhaique), to find a total of 210 persistently-infected participants. Persistently-infected adolescents will be included in a Second phase of this trial: A randomized, case-control, non-blinded study to either receive antimicrobial treatment targeting H. pylori eradication (cases) or no treatment (controls). A subset of 60 non-infected adolescents will be followed-up in matched times. This aims to provide evidence on the effect of treatment on clinical outcomes and serum biomarkers related to gastric damage, as well as composition and antimicrobial resistance of gut microbiota. The Investigators expect that eradication therapy will be successful in \>90% of persistently infected adolescents, with reinfection rates not surpassing 15% in a 2-3 year period, and to be associated with a decrease in clinical findings indicative of gastric disease, and a decrease in serum biomarker indicative of "gastric damage".
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
Contact & Investigator
Miguel O'Ryan, MD
PRINCIPAL INVESTIGATOR
University of Chile
Frequently Asked Questions
Who can join the NCT05926804 clinical trial?
This trial is open to participants of all sexes, aged 14 Years or older, up to 18 Years, studying Helicobacter Pylori Infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05926804 currently recruiting?
Yes, NCT05926804 is actively recruiting participants. Contact the research team at ylucero@uchile.cl for enrollment information.
Where is the NCT05926804 trial being conducted?
This trial is being conducted at Coyhaique, Chile, Santiago, Chile, Temuco, Chile.
Who is sponsoring the NCT05926804 clinical trial?
NCT05926804 is sponsored by Miguel O'Ryan Gallardo. The principal investigator is Miguel O'Ryan, MD at University of Chile. The trial plans to enroll 500 participants.