Pathogen-microbiome Interaction During Helicobacter Pylori Infection
ConditionHelicobacter Pylori Infection
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital Freiburg
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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.
Male and female (non-pregnant) volunteers between the ages of 18-65 years.
Disqualifiers
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
Trial population
Patients of full age who are capable of giving consent and from whom gastric biopsies, stool, and whole blood/serum will be obtained for diagnostic purposes (to exclude Helicobacter pylori infection), irrespective of the clinical picture. The indication for specimen collection is made by the treating clinical physician independent of the study. Patients should be informed about the study by the treating clinician concurrently with being informed about the risk of biopsy collection. Healthy volunteers will be invited to donate stool and blood for H. pylori diagnostics.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Analysis of gut microbiome and immune signatures
Diagnostic testThe 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.
Treatment groups
180 Participants
are divided into 3 treatment groupsGroup A: Helicobacter pylori patients1 intervention
Group B: Helicobacter pylori asymptomatic carriers1 intervention
Group C: Healthy controls1 intervention
Trial outcomes
Primary outcomes
1
Helicobacter pylori microbiome and immune signatures
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.
Time frame
12-18 MonthsSecondary outcomes
1
Helicobacter pylori eradication control
Patients with positive gastric biopsy for Helicobacter pylori will be assessed for successful eradication after treatment, and the eradication success will be compared with the patients' microbial signatures to identify specific gut microbial signatures that are associated with treatment outcome.
Time frame
12-24 MonthsSponsors and contacts
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Source ClinicalTrials.gov