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NCT05561504: HelicoPTER
Helicobacter Pylori Local Prevalence and Antibiotic Resistance
trial in Helicobacter Pylori Infection in 20,000 participants. Currently enrolling.
31 December 2025
Quick facts
| Lead sponsor | Technical University of Munich |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 20,000 |
| Start date | 31 March 2021 |
| Primary completion | 31 December 2025 |
| Estimated completion | 31 December 2035 |
| Sites | 1 location across Germany |
Conditions studied
- Helicobacter Pylori Infection — all drugs for Helicobacter Pylori Infection →
- Helicobacter Pylori Gastritis — all drugs for Helicobacter Pylori Gastritis →
- Drug Resistant Bacterial Infection — all drugs for Drug Resistant Bacterial Infection →
- Antibiotic Resistant Infection — all drugs for Antibiotic Resistant Infection →
Sponsor
Technical University of Munich
Who can join
18 and older, any sex, with Helicobacter Pylori Infection or Helicobacter Pylori Gastritis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05561504
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05561504 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Technical University of Munich
- Last refreshed: 30 November 2023
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