Persistent and transient Helicobacter pylori infections in early childhood.
Miguel L O'Ryan, Yalda Lucero, Marcela Rabello...
https://pubmed.ncbi.nlm.nih.gov/25838286Actively Recruiting
Phase Not Applicable
Age: 14Years - 18Years
All Genders
Healthy Volunteers
ID05926804
A Randomized Screen and Treat Helicobacter Pylori Eradication Trial in Adolescents Aged 14-18 in Three Chilean Regions Assessing Effectiveness and Microbiological-Host Implications
Led by Miguel O'Ryan Gallardo · Updated on 2025-12-17
500
Participants Needed
3
Research Sites
43 weeks
Total Duration
On this page
Sponsors
M
Miguel O'Ryan Gallardo
Lead Sponsor
F
Fondo Nacional de Desarrollo Científico y Tecnológico, Chile
Collaborating Sponsor
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
AI-Screening
AI-Powered Screening
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 to 3 visits over approximately 3 months for urea breath tests to confirm persistent H. pylori infection
Treatment
Duration - 14 days
Participants with persistent H. pylori infection receive a 14-day eradication therapy or no treatment depending on randomization.
1 baseline visit prior to treatment
Follow-up
Duration - Up to 18 months post treatment
Participants are monitored for eradication success, gastric disease markers, antimicrobial resistance, and gut microbiome changes.
Visits at 1 month, 3 months, 6 months, 9 months, and 18 months post treatment for breath tests, gastroenterological evaluations, and sample collections
Trial Site Locations
Total: 3 locations
1
Universidad de Aysén
Coyhaique, Chile
Actively Recruiting
2
Universidad de Chile
Santiago, Chile
Actively Recruiting
3
Universidad de la Frontera
Temuco, Chile
Actively Recruiting
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Research Team
Y
Yalda Lucero, MD, PhD
S
Sergio George, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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Published Research Related To This Trial
Dynamics of Helicobacter pylori detection in stools during the first 5 years of life in Chile, a rapidly developing country.
Miguel L O'Ryan, Marcela Rabello, Hector Cortés...
https://pubmed.ncbi.nlm.nih.gov/23076385Helicobacter pylori, clinical, laboratory, and noninvasive biomarkers suggestive of gastric damage in healthy school-aged children: A case-control study.
Yalda Lucero, Anne J Lagomarcino, Juan P Torres...
https://pubmed.ncbi.nlm.nih.gov/33278617Effect of Helicobacter pylori eradication therapy on clinical and laboratory biomarkers associated with gastric damage in healthy school-aged children: A randomized non-blinded trial.
Yalda Lucero, Anne J Lagomarcino, Juan P Torres...
https://pubmed.ncbi.nlm.nih.gov/34528337Protocol for a randomised 'screen-and-treat' Helicobacter pylori eradication trial in 14-18-years-old adolescents residing in three regions of Chile: effectiveness and microbiological host implications.
Sergio George, Yalda Lucero, Camila Cabrera...
https://pubmed.ncbi.nlm.nih.gov/39890135