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

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 - ERANET - Bavaria

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00028629

Enrollment

300

Registered

2022-04-11

Start date

2020-11-12

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

K29.7 C16.9

Interventions

Group 1: Controls: patients who undergo routine EGD to investigate dyspepsia and have normal findings. Like in other arms blood samples, biopsies, saliva and gastric juice are collected as part of the

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
- 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 - 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.	—

Measure

Time frame

- 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 - 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.

—

Countries

Germany

Contacts

Public ContactRiccardo Vasapolli

Medizinische Klinik und Poliklinik 2, LMU Klinikum

riccardo.vasapolli@med.uni-muenchen.de+4908944000

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026