NCT05561504Recruiting
Helicobacter Pylori Local Prevalence and Antibiotic Resistance
HelicoPTER - Bestimmung Der Lokalen Helicobacter Pylori Prävalenz Und Antibiotika Resistenzlage
Source: ClinicalTrials.gov · Last updated 30 Nov 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 20000 (estimated)
- First submitted
- 27 Sept 2022
- Start date
- 31 Mar 2021
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- Technical University of Munich
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT05561504
What you commit to
- Study type: Observational
- Planned participants: 20000
- From 31 Mar 2021 to the primary completion date, 31 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- no capacity to consent
Who the study is looking for
- Minimum age of 18 years
- informed consent for HelicoPTER study
- informed consent for HEPY biobank
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Medicine II, University Hospital of Munich Coordinator of this site? Confirm its status | Munich | Germany | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.