Understanding how Helicobacter pylori affects the gut microbiome
Pathogen-microbiome Interaction in Human Response and Disease-outcome During Infection and Colonization With Helicobacter Pylori
University Hospital Freiburg · NCT05121025
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 type | Observational |
|---|---|
| Enrollment | 180 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital Freiburg (other) |
| Locations | 1 site (Freiburg im Breisgau, Baden-Wurttemberg) |
| Trial ID | NCT05121025 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who are undergoing diagnostic procedures for Helicobacter pylori infection.
Not a fit: Patients who are minors, unable to provide consent, or have not consented to testing will not benefit from this study.
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 performed: Previous studies have indicated that understanding microbiome interactions can influence treatment outcomes, suggesting potential success for this approach.
Eligibility criteria
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 this trial is running
Freiburg im Breisgau, Baden-Wurttemberg
- Institute for Microbiology and Hygiene — Freiburg im Breisgau, Baden-Wurttemberg, Germany (RECRUITING)
Study contacts
- Study coordinator: Mohamed Tarek Badr, M.D.
- Email: mohamed.tarek.badr@uniklinik-freiburg.de
- Phone: 00497612036585
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Helicobacter Pylori Infection, Helicobacter Pylori, Metagenomics