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 type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 180 (estimated) |
| Sponsor | University Hospital Freiburg Academic / other |
| Locations | 1 site (Freiburg im Breisgau, Baden-Wurttemberg) |
| Status | Recruiting |
| Started | March 11, 2022 |
| Main results expected | June 30, 2025 |
| Study ends | December 30, 2025 |
| Registry record updated | December 5, 2024 |
| Trial ID | NCT05121025 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
- Study coordinator: Mohamed Tarek Badr, M.D.
- Email: mohamed.tarek.badr@uniklinik-freiburg.de
- Phone: 00497612036585
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Fecal transplant to help eradicate stubborn Helicobacter pylori infection
This study tests whether giving a fecal microbiota transplant can help people with Helicobacter pylori infection that has not responded to standard treatments.
-
Fecal-guided simplified vonoprazan plus clarithromycin first-line therapy for H. pylori
We are testing whether a two-drug regimen of vonoprazan plus clarithromycin clears H. pylori in adults whose fecal PCR shows no clarithromycin resistance mutations.
-
Bismuth-amoxicillin-vonoprazan triple therapy versus bismuth-based quadruple therapy for H. pylori infection
This will test whether a 14-day bismuth-amoxicillin-vonoprazan triple therapy works better and is as safe as a 14-day bismuth-based quadruple therapy for adults with H. pylori infection.
-
P-CABs plus bismuth quadruple treatment for Helicobacter pylori infection
This study tests whether using potassium-competitive acid blockers (P-CABs) in bismuth-containing quadruple therapy works better and is safe for adults with H. pylori infection.
-
Bismuth versus no bismuth for treating H. pylori-related stomach and duodenal ulcers in children
This project will try adding bismuth to standard antibiotic and PPI treatment to see if it helps clear H. pylori and heal ulcers in children.
-
Tegoprazan 50 mg twice daily plus amoxicillin versus vonoprazan 20 mg twice daily plus amoxicillin for H. pylori eradication
This trial tests whether a 14-day tegoprazan plus amoxicillin regimen works as well as a vonoprazan plus amoxicillin regimen to cure Helicobacter pylori infection in adults.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.