A "Screen and Treat" Helicobacter Pylori Eradication Trial in Adolescents in Three Regions of Chile
Status:
Recruiting
Trial end date:
2026-03-31
Target enrollment:
Participant gender:
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 1000
asymptomatic adolescents 14-18 years of age from 3 cities of Chile (Colina, Temuco and
Coyhaique), to find a total of 200-250 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".
Phase:
N/A
Details
Lead Sponsor:
Miguel O'Ryan Gallardo
Collaborator:
Fondo Nacional de Desarrollo Científico y Tecnológico, Chile