Randomized Helicobacter Pylori Screen and Treat Study in Adolescents Aged 14 to 18 From Three Chilean Regions to Assess Eradication and Its Effects on Gastric Health and Gut Microbiome

What this Trial Is About

Gastric cancer is a serious health issue worldwide, with Chile experiencing some of the highest death rates. Helicobacter pylori infection is common among Chilean adults and is the main cause of gastric cancer. This research focuses on early detection and treatment of H. pylori infection in adolescents aged 14 to 18, aiming to reduce gastric damage and improve health outcomes by using a screen and treat strategy in areas with moderate to high gastric cancer rates. The study begins by screening up to 1000 asymptomatic adolescents in three Chilean cities to identify those persistently infected with H. pylori. Those confirmed with persistent infection will be randomly assigned to receive either a 14-day antimicrobial treatment including lansoprazole, amoxicillin, clarithromycin, and metronidazole, or no treatment. A group of 60 non-infected adolescents will also be followed for comparison. The study includes pre-treatment and multiple post-treatment evaluations over 18 months. Participants will undergo repeated urea breath tests to monitor infection status, gastroenterological exams, and collection of blood and stool samples to measure biomarkers of gastric damage and analyze gut microbiome changes. Researchers will assess the success of eradication therapy, reinfection rates, clinical signs of gastric disease, and changes in antimicrobial resistance and gut microbiota diversity. The total follow-up period includes regular check-ups up to 18 months post-treatment, with additional monitoring of non-infected participants.

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