Assessing H. pylori infection rates and antibiotic resistance in Germany
HelicoPTER - Bestimmung Der Lokalen Helicobacter Pylori Prävalenz Und Antibiotika Resistenzlage
This study is trying to find out how common H. pylori infections are in Germany and if the bacteria are resistant to antibiotics, so doctors can better treat patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Technical University of Munich Academic / other |
| Locations | 1 site (Munich) |
| Trial ID | NCT05561504 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the prevalence of Helicobacter pylori infections and the rates of antibiotic resistance in Germany. It involves screening volunteers for H. pylori infection through serology, followed by confirmation via breath tests and long-term observation for those who test positive. Patients undergoing endoscopy will have biopsies taken to analyze antibiotic resistance, and a biobank will be established for further molecular analysis. The study seeks to provide essential data for effective treatment regimens based on local resistance patterns.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who can provide informed consent and are suspected of having H. pylori infection.
Not a fit: Patients who lack the capacity to consent or are under 18 years old will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for H. pylori infections, enhancing patient outcomes and reducing antibiotic resistance.
How similar studies have performed: While there is limited data from small cohorts in Germany, similar studies in other regions have successfully assessed H. pylori prevalence and antibiotic resistance, indicating potential for valuable insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Minimum age of 18 years * informed consent for HelicoPTER study * informed consent for HEPY biobank Exclusion Criteria: * no capacity to consent
Where this trial is running
Munich
- Department of Medicine II, University Hospital of Munich — Munich, Germany (Recruiting)
Study contacts
- Principal investigator: Markus Gerhard, Prof. — Technical University of Munich
- Study coordinator: Markus Gerhard, Prof.
- Email: markus.gerhard@tum.de
- Phone: +49894140
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.