About this trial
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
This trial accepts healthy volunteersQualifiers
Minimum age of 18 years
informed consent for HelicoPTER study
informed consent for HEPY biobank
Disqualifiers
no capacity to consent
Trial population
unselected group of participants
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
H. pylori prevalence
Prevalence of H. pylori infection in a random sample of the populations of Munich, Tübingen, Hannover, Regensburg, Magdeburg and their respective surroundings
H. pylori resistance profiles
H. pylori isolation and antibiotic resistance testing from gastric mucosa biopsies
Secondary outcomes
H. pylori strain analyses
H. pylori subtype determination via antibody responses in serum and sequencing of H. pylori strains
subsequent medical events
survey-based follow up of participants at 5 and 10 years for subsequent medical conditions
risk factors for gastric cancer
Correlation of microbiological and serological findings with gastric histopathology and subsequent cancer diagnoses
Sponsors and contacts
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