Helicobacter Pylori Local Prevalence and Antibiotic Resistance (HelicoPTER)

HelicoPTER - Bestimmung Der Lokalen Helicobacter Pylori Prävalenz Und Antibiotika Resistenzlage

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.

Study Overview

• Status: Recruiting
• Conditions: Gastric Cancer; Microbial Colonization; Helicobacter Pylori Infection; Antibiotic Resistant Infection; Helicobacter Pylori Gastritis; Drug Resistant Bacterial Infection

Detailed Description

Infection with H. pylori occurs in childhood and usually leads to lifelong persistence of the pathogen. The prevalence of the infection depends on socioeconomic status (occupation, income, housing situation), especially during childhood, when the transmission occurs most frequently. H. pylori infections are most common in East Asia, e.g. China, with prevalence rates of around 60-80 %, and in Africa, with prevalence rates of partly over 80 %. In Europe, there is a south-north divide in infection rates with a higher prevalence in southern countries. The prevalence in Germany varies between 21% for the Hannover area and 44% for Saxony-Anhalt; the prevalence in children is significantly lower than in adults. Current data on the larger population in Germany are lacking. While antibiotics in combination with PPIs can be used to treat the infection, rising antibiotic resistance rates reduce effectiveness of eradication regimens.

We therefore initiated a multicenter observational study to assess the prevalence of H. pylori infection and antibiotic resistance rates in Germany. In Part A, volunteers are screened for H. pylori infection by serology. If the test is positive, a breath test is performed for confirmation and further visits and examinations follow for long-term observation. Positive patients undergoing endoscopy can enter Part B, in which biopsies are taken for antibiotic resistance, and establishment of a serum, stool and a tissue bank for molecular analysis including microbiome sequencing.

Part A - Primary study objectives - screening phase The primary aim of this part of the study is to collect data on the prevalence of H. pylori in an age- and gender-stratified random sample of the populations of Munich, Tübingen, Hannover, Regensburg, and Magdeburg and their respective surroundings. If the initial serologic test is negative, no further study visits are planned for these subjects. The serum samples already collected will be used as control samples for the serologic study. If the serologic test is positive, a breath test is performed for confirmation. If the confirmatory breath test is positive and the subject is evaluated by his/her primary doctor and deemed a candidate for endoscopic evaluation, then s/he is referred for participation in part B of the study.

Part B - Secondary study objectives - investigation phase

As secondary study objectives, the following should be investigated in H. pylori infected study participants:

• Establishment of a patient cohort for long-term observation (5-10 years).

• Establishment of a serum, stool and tissue bank in this cohort for subsequent testing:

  • H. pylori subtype determination for gastric cancer risk, early detection via antibody responses in serum, identification of risk factors
  • PCR or sequencing of H. pylori strains (from stomach biopsy or stool sample)
  • H. pylori isolation and antibiotic resistance testing from gastric mucosa biopsies, only to be performed as part of a clinically indicated esophago-gastro- duodenoscopy - ÖGD (for diagnosis before initiation of therapy or also after completion of therapy to monitor success or progression)
  • Correlation of microbiological findings with histopathological findings and atrophy markers.
• Determination of H. pylori associated microbiome characteristics and microbiome changes after eradication therapy

Only patients undergoing gastroscopy for clinical indications are included into Part B of the study

• Study Type: Observational
• Enrollment (Estimated): 20000

Contacts and Locations

• Study Contact: Name: Markus Gerhard, Prof.; Phone Number: 2477 +49894140; Email: markus.gerhard@tum.de

Study Locations

• Germany
  • Munich, Germany
    • Recruiting
    • Department of Medicine II, University Hospital of Munich
    • Contact: Christian Schulz, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

unselected group of participants

Description

Inclusion Criteria:

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

Exclusion Criteria:

• no capacity to consent

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
H. pylori strain analyses	H. pylori subtype determination via antibody responses in serum and sequencing of H. pylori strains	1 year
subsequent medical events	survey-based follow up of participants at 5 and 10 years for subsequent medical conditions	10 years
risk factors for gastric cancer	Correlation of microbiological and serological findings with gastric histopathology and subsequent cancer diagnoses	10 years

Collaborators and Investigators

• Sponsor: Technical University of Munich
• Investigators: Principal Investigator: Markus Gerhard, Prof., Technical University of Munich

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2021
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2035

Study Registration Dates

• First Submitted: September 27, 2022
• First Submitted That Met QC Criteria: September 27, 2022
• First Posted (Actual): September 30, 2022

Study Record Updates

• Last Update Posted (Actual): November 30, 2023
• Last Update Submitted That Met QC Criteria: November 29, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease Attributes; Gastrointestinal Diseases; Stomach Diseases; Gastroenteritis; Bacterial Infections and Mycoses; Gastritis; Infections; Communicable Diseases; Bacterial Infections
• Other Study ID Numbers: GI 06.827

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: IPD will be made available after closing of recruitment (12/2025) for a duration of 10 years
• IPD Sharing Access Criteria: data transfer request with detailed outline of scientific questions and aims
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No