Pathogen-microbiome Interaction During Helicobacter Pylori Infection

NCT05121025 | Recruiting

• 1 other identifier: 21/1552
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Helicobacter Pylori Infection

Keywords

Helicobacter Pylori; Metagenomics

Outcome Measures

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.

  12-18 Months

Secondary Outcomes (1)

• Helicobacter pylori eradication control

  12-24 Months

Study Arms (3)

Helicobacter pylori patients

Patients with gastric biposies which was positive for Helicobacter pylori in culture

Diagnostic Test: Analysis of gut microbiome and immune signatures

Helicobacter pylori asymptomatic carriers

Healthy controls who are positive for Helicobacter pylori antigen in stool and have no symptoms of gastritis

Diagnostic Test: Analysis of gut microbiome and immune signatures

Healthy controls

Healthy controls who are negative for Helicobacter pylori antigen in stool and have no symptoms of gastritis

Diagnostic Test: Analysis of gut microbiome and immune signatures

Interventions

Analysis of gut microbiome and immune signatures DIAGNOSTIC_TEST

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.

Healthy controls; Helicobacter pylori asymptomatic carriers; Helicobacter pylori patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Freiburg: lead

Study Sites (1)

Institute for Microbiology and Hygiene

Freiburg im Breisgau, Baden-Wurttemberg, 79104, Germany

RECRUITING

Central Study Contacts

Mohamed Tarek Badr, M.D.

CONTACT

00497612036585; mohamed.tarek.badr@uniklinik-freiburg.de

Anne Lichtenegger

CONTACT

00497612036585; anne.sophie.lichtenegger@uniklinik-freiburg.de

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 25, 2021
• First Posted: November 16, 2021
• Study Start: March 11, 2022
• Primary Completion: June 30, 2025
• Study Completion: December 30, 2025
• Last Updated: December 5, 2024

Record last verified: 2024-12

Locations

DE (1)