What is this trial studying for Helicobacter pylori infection?

This trial is studying the effectiveness of eradicating Helicobacter pylori infection in adolescents aged 14 to 18 in three regions of Chile. Researchers want to understand how treatment affects stomach health, infection status, and gut bacteria. The study is led by Miguel O'Ryan Gallardo and aims to provide evidence supporting early detection and treatment strategies.

Who may be eligible for this Helicobacter pylori infection clinical trial?

Teenagers aged 14 to 18 living in certain Chilean regions who are generally healthy may be eligible. They need to have persistent H. pylori infection confirmed by tests or be non-infected controls. Anyone with recent antibiotic use, prior eradication therapy, pregnancy, or allergies to study drugs may not qualify. Please review eligibility criteria for more details.

Is there any cost to participate in this Helicobacter pylori infection clinical trial?

Study-related care, including the study drugs and all trial visits, is provided at no cost. However, personal travel expenses to attend study visits may vary and are not guaranteed to be covered. Participants can plan accordingly for any travel needs during the study.

Actively Recruiting

Phase Not Applicable

Age: 14Years - 18Years

All Genders

Healthy Volunteers

ID05926804

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

Led by Miguel O'Ryan Gallardo · Updated on 2025-12-17

500

Participants Needed

Research Sites

43 weeks

Total Duration

AI-Summary

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.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 14Years - 18Years

All Genders

Healthy Volunteers

Eligibility Criteria

You may qualify if you...

Healthy teenagers aged 14 to 18 years from Colina, Temuco, or Coyhaique
At least one responsible adult family member available for phone contact
Persistent H. pylori infection confirmed by at least two positive urea breath tests within three months (except for non-infected controls)

You will not qualify if you...

Teenagers who do not consent to treatment may continue as non-treated controls
Known allergy to any antimicrobials used in the trial (except non-infected controls)
Presence of symptoms suggesting organic abdominal pain such as persistent right upper or lower quadrant pain, difficulty swallowing, painful swallowing, persistent vomiting, gastrointestinal bleeding, involuntary weight loss, slowed growth, or delayed puberty
Previous H. pylori eradication therapy
Use of antibiotics within the past month (at least 3 days of treatment at proper dose)
Pregnancy
Use of immunosuppressive or biologic drugs
Deemed not healthy by study physician after questionnaire review

Research Team

Yalda Lucero, MD, PhD

Sergio George, MD, PhD

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here