Determination and multi-modal characterization of local Helicobacter pylori infection, of the influence of the microbiome of the upper gastrointestinal tract on gastric carcinogenesis and prospective evaluation of a serological biopsy for risk assessment of H. pylori infection: the ERANET-Bavaria study

Recruiting

• Conditions: K29.7; C16.9; Gastritis, unspecified; Stomach, unspecified

• Registration Number: DRKS00028629
• Lead Sponsor: Klinikum der Universität München, Campus Großhadern

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-04-11
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Patients/subjects over 18 years of age;

- ability to consent to study participation;

- no therapy with anticoagulants that do not allow biopsy sampling;

- existing stomach without surgically altered anatomy;

- no antibiotic therapy within the last four weeks.

Exclusion Criteria

- Previous gastrectomy or presence of other relevant anatomical changes resulting from surgical interventions of the stomach;

- age under 18 years;

- impossibility of informed consent;

- antibiotic therapy within the last four weeks;

- therapies or coagulation disorders that do not allow biopsy sampling.

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Detailed Analysis of H. pylori-Infection including:<br><br>- Determination of the local H. pylori antibiotic resistances, considering specific bacterial virulence factors and phenotypic and genotypic characterization of local H. pylori strains<br><br>- Analysis of the host-specific mucosal immune response and the susceptibility of the gastric mucosa to chronic infection

Secondary Outcome Measures

Name	Time	Method
- Characterization of the mucosal microbiome with focus on metabolically active bacteria as well as of the metabolome and lipidome profiles in correlation to the different anatomical and physiological regions of the stomach and the severity of gastritis<br><br>- Evaluation of new tools for H. pylori diagnostics, with regard to sensitivity and specificity, in comparison to non-invasive and invasive H. pylori standard diagnostic methods.