Clinical trial · Observational
Helicobacter Pylori Local Prevalence and Antibiotic Resistance
HelicoPTER - Bestimmung Der Lokalen Helicobacter Pylori Prävalenz Und Antibiotika Resistenzlage
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Antibiotic Resistant Infection | — | UNRESOLVED | — |
| Drug Resistant Bacterial Infection | — | UNRESOLVED | — |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Helicobacter Pylori Gastritis | — | UNRESOLVED | — |
| Helicobacter Pylori Infection | — | UNRESOLVED | — |
| Microbial Colonization | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- H. pylori prevalence
- timeFrame
- 6 months
- description
- Prevalence of H. pylori infection in a random sample of the populations of Munich, Tübingen, Hannover, Regensburg, Magdeburg and their respective surroundings
- measure
- H. pylori resistance profiles
- timeFrame
- 6 months
- description
- H. pylori isolation and antibiotic resistance testing from gastric mucosa biopsies
Secondary outcomes (3)
- measure
- H. pylori strain analyses
- timeFrame
- 1 year
- description
- H. pylori subtype determination via antibody responses in serum and sequencing of H. pylori strains
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Minimum age of 18 years * informed consent for HelicoPTER study * informed consent for HEPY biobank Exclusion Criteria: * no capacity to consent
References
Publications (0)
Data not yet available