Helicobacter Pylori Local Prevalence and Antibiotic Resistance

NCT05561504 | Recruiting

• 1 other identifier: GI 06.827
• Study Type: observational
• Target: 20,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Helicobacter Pylori Infection; Helicobacter Pylori Gastritis; Drug Resistant Bacterial Infection; Antibiotic Resistant Infection; Gastric Cancer; Microbial Colonization

Outcome Measures

Primary Outcomes (2)

• 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

  6 months

• H. pylori resistance profiles

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

  6 months

Secondary Outcomes (3)

• H. pylori strain analyses

  1 year

• subsequent medical events

  10 years

• risk factors for gastric cancer

  10 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

unselected group of participants

You may qualify if:

• Minimum age of 18 years
• informed consent for HelicoPTER study
• informed consent for HEPY biobank

You may not qualify if:

• no capacity to consent

Sponsors & Collaborators

• Technical University of Munich: lead

Study Sites (1)

Department of Medicine II, University Hospital of Munich

Munich, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

blood samples, fecal samples, gastric biopsies

MeSH Terms

Conditions

Stomach Neoplasms; Communicable Diseases

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Markus Gerhard, Prof.

  Technical University of Munich

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Markus Gerhard, Prof.

CONTACT

+49894140; markus.gerhard@tum.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2022
• First Posted: September 30, 2022
• Study Start: March 31, 2021
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2035
• Last Updated: November 30, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: IPD will be made available after closing of recruitment (12/2025) for a duration of 10 years
• Access Criteria: data transfer request with detailed outline of scientific questions and aims

Locations

DE (1)