Helicobacter Pylori Local Prevalence and Antibiotic Resistance

Studien-Informationen Einschlusskriterien Studien-Rationale

Rekrutierend

NCT-Nummer:
NCT05561504

Studienbeginn:
März 2021

Letztes Update:
30.11.2023

Wirkstoff:
-

Indikation (Clinical Trials):
Infections, Communicable Diseases, Bacterial Infections, Gastritis

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Technical University of Munich

Collaborator:
-

Studienleiter

Markus Gerhard, Prof.
Principal Investigator
Technical University of Munich

Kontakt

Markus Gerhard, Prof.
Kontakt:
Phone: +49894140
Phone (ext.): 2477
E-Mail: markus.gerhard@tum.de» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

Department of Medicine II, University Hospital of Munich
Munich
(Bayern)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Christian Schulz, MD» Ansprechpartner anzeigen

Studien-Informationen

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

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Minimum age of 18 years

- informed consent for HelicoPTER study

- informed consent for HEPY biobank

Exclusion Criteria:

- no capacity to consent

Studien-Rationale

Primary outcome:

1. H. pylori prevalence (Time Frame - 6 months):
Prevalence of H. pylori infection in a random sample of the populations of Munich, Tübingen, Hannover, Regensburg, Magdeburg and their respective surroundings

2. H. pylori resistance profiles (Time Frame - 6 months):
H. pylori isolation and antibiotic resistance testing from gastric mucosa biopsies

Secondary outcome:

1. H. pylori strain analyses (Time Frame - 1 year):
H. pylori subtype determination via antibody responses in serum and sequencing of H. pylori strains

2. subsequent medical events (Time Frame - 10 years):
survey-based follow up of participants at 5 and 10 years for subsequent medical conditions

3. risk factors for gastric cancer (Time Frame - 10 years):
Correlation of microbiological and serological findings with gastric histopathology and subsequent cancer diagnoses

Quelle: ClinicalTrials.gov

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