Actively Recruiting
HelicoPTER - Determining Local Helicobacter Pylori Prevalence and Antibiotic Resistance in Germany
Led by Technical University of Munich · Updated on 2023-11-30
20000
Participants Needed
1
Research Sites
521 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the prevalence of Helicobacter pylori infection and antibiotic resistance in Germany, focusing on how socioeconomic factors and age influence infection rates. The study aims to improve detection methods and identify patients at high risk of gastric cancer or precancerous lesions by examining factors such as gastric microbiome signatures. This observational study is designed to gather important data for better risk stratification and treatment decisions. The study is divided into two parts. In Part A, volunteers are screened for H. pylori infection using serologic testing followed by a breath test for confirmation if positive. Participants with confirmed infections who are candidates for endoscopy can enter Part B, where biopsies are collected during clinically indicated gastroscopies to test for antibiotic resistance and to build a biobank for molecular analyses, including microbiome sequencing. Part B also involves long-term observation and detailed laboratory investigations. Participants will undergo initial screening and, if positive, further diagnostic tests including breath tests and endoscopic biopsies when clinically indicated. Researchers will collect and analyze serum, stool, and tissue samples for bacterial subtype, resistance profiles, and microbiome characteristics. The study monitors prevalence and resistance data at 6 months, strain analyses at 1 year, and tracks medical events and cancer risk factors over 10 years. This long-term follow-up provides comprehensive data to support future treatment and prevention strategies.
CONDITIONS
Brief Title
Helicobacter Pylori Local Prevalence and Antibiotic Resistance
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Minimum age of 18 years
- Informed consent for HelicoPTER study
- Informed consent for HEPY biobank
You will not qualify if you...
- No capacity to consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 months
Participants who test positive for H. pylori are observed through breath tests and medical evaluations to confirm infection and monitor health status.
1 to 2 visits depending on test results
Duration - Up to 10 years
Participants positive for H. pylori and undergoing clinically indicated gastroscopy are followed for long-term observation including collection of samples for molecular analysis and assessment of medical events and risk factors.
Periodic visits as clinically indicated over 10 years
Trial Site Locations
Total: 1 location
1
Department of Medicine II, University Hospital of Munich
Munich, Germany
Actively Recruiting
Research Team
M
Markus Gerhard, Prof.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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