NCT05561504 Helicobacter Pylori Local Prevalence and Antibiotic Resistance
| NCT ID | NCT05561504 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Technical University of Munich |
| Condition | Helicobacter Pylori Infection |
| Study Type | OBSERVATIONAL |
| Enrollment | 20,000 participants |
| Start Date | 2021-03-31 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 20,000 participants in total. It began in 2021-03-31 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The clinical management of H. pylori infection depends essentially on two factors, prevalence and local resistance. In Germany, only limited data from rather small cohorts currently exist regarding both factors. Knowledge of the current prevalence (accounting for socioeconomic factors and age) is important for the selection of suitable detection methods, as this influences the positive and negative predictive value of the respective diagnostic methods. Current data on antibiotic resistance are essential for efficient therapy. In this clinical study, we will collect data on the frequency and severity of H. pylori infections and then, after endoscopic examination, on antibiotic resistance. Knowledge of the resistance situation is necessary for the selection of suitable therapeutic regimens. Furthermore, molecular methods for resistance detection are to be compared with conventional microbiological methods in order to be able to detect resistance more quickly. Furthermore, we aim to identify specific parameters for early detection of patients at particularly high risk of gastric cancer or with precancerous lesions due to infection. The aim is to identify carcinogenesis-relevant factors such as gastric microbiome signatures that will make it possible to identify patients who are most likely to benefit from prophylactic eradication therapy in terms of risk stratification.
Eligibility Criteria
Inclusion Criteria: * Minimum age of 18 years * informed consent for HelicoPTER study * informed consent for HEPY biobank Exclusion Criteria: * no capacity to consent
Contact & Investigator
Markus Gerhard, Prof.
PRINCIPAL INVESTIGATOR
Technical University of Munich
Frequently Asked Questions
Who can join the NCT05561504 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Helicobacter Pylori Infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05561504 currently recruiting?
Yes, NCT05561504 is actively recruiting participants. Contact the research team at markus.gerhard@tum.de for enrollment information.
Where is the NCT05561504 trial being conducted?
This trial is being conducted at Munich, Germany.
Who is sponsoring the NCT05561504 clinical trial?
NCT05561504 is sponsored by Technical University of Munich. The principal investigator is Markus Gerhard, Prof. at Technical University of Munich. The trial plans to enroll 20,000 participants.