Clinical trial Recruiting at 1 site Observational Ages 18 and up

Understanding how Helicobacter pylori affects the gut microbiome

Official title: Pathogen-microbiome Interaction in Human Response and Disease-outcome During Infection and Colonization With Helicobacter Pylori

Run by University Hospital Freiburg · NCT05121025 · Data updated 2026-11-12

This study looks at how an infection with Helicobacter pylori affects the gut bacteria in people to see if these changes can help predict how severe the infection is and how well treatments work.

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment180 (estimated)
SponsorUniversity Hospital Freiburg
Academic / other
Locations1 site (Freiburg im Breisgau, Baden-Wurttemberg)
StatusRecruiting
StartedMarch 11, 2022
Main results expectedJune 30, 2025
Study endsDecember 30, 2025
Registry record updatedDecember 5, 2024
Trial IDNCT05121025 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include adults aged 18 and older who are undergoing diagnostic procedures for Helicobacter pylori infection.

Probably not a fit

Patients who are minors, unable to provide consent, or have not consented to testing will not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study investigates the interactions between Helicobacter pylori infection and the human gut microbiome. It aims to determine how changes in the microbiome, as measured through stool samples, can predict the severity of H. pylori-related diseases and treatment outcomes. The study will analyze the gut microbiome and immune responses in patients and healthy volunteers to uncover the mechanisms behind microbial imbalances caused by H. pylori. By exploring these relationships, the research seeks to provide insights into the role of the microbiome in H. pylori infections.

Why it matters

Potential benefit: If successful, this study could lead to improved understanding and treatment strategies for Helicobacter pylori infections and their associated diseases.

How similar studies have gone: Previous studies have indicated that understanding microbiome interactions can influence treatment outcomes, suggesting potential success for this approach.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • Institute for Microbiology and Hygiene
    Freiburg im Breisgau, Baden-Wurttemberg, Germany
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.