Analysis of gut microbiome and immune signatures: The investigators will analyse the microbiome composition (16S rDNA-sequencing and metagenomics), microbiome activity (RNA-sequencing of stool bacteria and metabolite sampling) and immune cell activity (leukocyte RNA-sequencing) of all study groups.
Study summary
Helicobacter pylori affects the gut microbiome in ways that are only partially understood. In which patients H. pylori causes severe disease and in whom it merely colonizes, possibly even with beneficial effects, is not understood. The investigators are pursuing the hypothesis that changes in the gut microbiome that can be easily measured in stool have such predictive value.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria:
Patients: -
* Male and female patients aged ≥ 18 years.
* Specimens from patients undergoing tissue sampling, stool, and blood to rule out Helicobacter pylori infection
* Written informed consent from patients.
Volunteer subjects: -
* Male and female (non-pregnant) volunteers between the ages of 18-65 years.
* Written informed consent from volunteers.
* No acute medical conditions
* No regular medication use, and no antibiotic use in the last 4 weeks.
Exclusion Criteria:
Patients: -
* Minor patients
* Patients not capable of giving consent
* Samples without sufficient residual material after standard diagnostic procedures
* Samples from patients who have not given consent for testing
Volunteer subjects: -
* Subjects not capable of giving consent
* Subjects with acute illnesses
* Subjects older than 65 or younger than 18 years of age.
* Pregnant women
Primary outcome measure(s)
Helicobacter pylori microbiome and immune signatures — 12-18 Months The diversity of the gut microbial species of patients and controls as well as transcriptomic signatures of blood immune cells will be assessed and compared to conclude specisifc signatures that are associated with the disease and carrier status. These signatures will be analyzed to identify specific bacterial and immune biomarkers that can be used as a screening tool for Helicobacter pylori infection.
Trial sites (1)
Facility
City
Region
Status
Institute for Microbiology and Hygiene
Freiburg im Breisgau
Baden-Wurttemberg
Recruiting
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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