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Clinical Trials in Germany / NCT05121025
Recruiting Observational

Pathogen-microbiome Interaction During Helicobacter Pylori Infection

NCT05121025 · tracked via the Priya Life Science Germany tracker
Phase
Observational
Started
2022-03-11
Last updated
2024-12-05

Condition(s) studied

Helicobacter Pylori Infection

Investigational drug(s) / intervention(s)

Analysis of gut microbiome and immune signatures

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)

Trial sites (1)

FacilityCityRegionStatus
Institute for Microbiology and Hygiene Freiburg im Breisgau Baden-Wurttemberg Recruiting

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Other trials for the same condition

Official registry record

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.

View NCT05121025 on ClinicalTrials.gov ↗ ← All trials in Germany