Helicobacter Pylori Local Prevalence and Antibiotic Resistance

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorTechnical University of Munich

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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

Time frame
6 months
2

H. pylori resistance profiles

H. pylori isolation and antibiotic resistance testing from gastric mucosa biopsies

Time frame
6 months

Secondary outcomes

1

H. pylori strain analyses

H. pylori subtype determination via antibody responses in serum and sequencing of H. pylori strains

Time frame
1 year
2

subsequent medical events

survey-based follow up of participants at 5 and 10 years for subsequent medical conditions

Time frame
10 years
3

risk factors for gastric cancer

Correlation of microbiological and serological findings with gastric histopathology and subsequent cancer diagnoses

Time frame
10 years

Other outcomes

Sponsors and contacts

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