Helicobacter Pylori InfectionPREDICTHPNCT05121025
Pathogen-microbiome Interaction During Helicobacter Pylori Infection
An observational study of Helicobacter Pylori Infection, run by University Hospital Freiburg at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- Analysis of gut microbiome and immune signatures
- How many people
- 180 participants
- Where
- 1 siteGermany
- Study dates
- 11 Mar 2022to 30 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
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- Written informed consent from volunteers.
- No acute medical conditions
- No regular medication use, and no antibiotic use in the last 4 weeks.
Who cannot join
- 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: -
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- Subjects not capable of giving consent
- Subjects with acute illnesses
- Subjects older than 65 or younger than 18 years of age.
- Pregnant women
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Institute for Microbiology and Hygiene
Freiburg im Breisgau, Baden-Wurttemberg, 79104
Mohamed Tarek Badr, MD
About this study
Official title: Pathogen-microbiome Interaction in Human Response and Disease-outcome During Infection and Colonization With Helicobacter Pylori
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.
Read the detailed description
Helicobacter pylori colonizes the stomach of about half of the world's population, including about 20-30% of adults in Germany. In some cases, this colonization can lead to chronic inflammation of the gastric mucosa, which can lead to various serious diseases such as ulcer disease and gastric cancer. It has been reported several times in the literature that Helicobacter pylori infection negatively affects the human intestinal flora and can lead to microbial imbalance (dysbiosis). Recent studies, mostly from mouse models, reveal new roles and interactions of the microbiome: host immune response may influence bacterial activity; bacterial metabolites may determine microbiome functions. Differences in the microbiome were also found between Helicobacter pylori-infected patients and were associated with treatment success. On the other hand, beneficial microbial symbiosis may prevent intestinal inflammation. The reasons for these differences in the microbiome of Helicobacter pylori-infected patients, which may also contribute to treatment failure, remain to be investigated. Therefore, this project aims to investigate how Helicobacter pylori affects the bacteria and fungi of the human gastrointestinal microbiome and how the suspected microbial imbalance may influence treatment success. In this project, The investigators aim to answer the question of how these newly discovered mechanisms alter the course of human H. pylori infection. The investigators will analyze H. pylori itself in colonized patients and asymptomatic individuals (whole genome sequencing), determine the immune response of the carrier (RNA expression in lymphocytes), and composition of the gut microbiome (DNA sequencing) and activity (RNA expression in the bacteria/fungi and identification of metabolites). Using bioinformatics approaches, particularly machine learning, The investigators will determine the parameters that predict disease progression and eradication success. The results will provide important decision support for H. pylori-infected patients.
- Conditions
- Helicobacter Pylori Infection
- Being tested
- Analysis of gut microbiome and immune signatures
- Keywords
- Helicobacter Pylori, Metagenomics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Analysis of gut microbiome and immune signaturesDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Helicobacter pylori patients | Patients with gastric biposies which was positive for Helicobacter pylori in culture Receives: 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 Receives: 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 Receives: Diagnostic Test: Analysis of gut microbiome and immune signatures |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12-18 Months
Secondary 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.
Measured: 12-24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2021
- Study start11 Mar 2022
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Helicobacter Pylori InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Freiburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Tarek Badr, University Hospital Freiburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05121025
- Sponsor's protocol ID
- 21/1552
- Acronym
- PREDICTHP
- Status last verified
- Dec 2024
- First submitted
- 25 Oct 2021
- Last updated
- 5 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pathogen-microbiome Interaction in Human Response and Disease-outcome During Infection and Colonization With Helicobacter Pylori
- ClinicalTrials.gov ID
- NCT05121025
- Acronym / sponsor ID
- PREDICTHP / 21/1552
- Conditions
- Helicobacter Pylori Infection
- Keywords
- Helicobacter Pylori, Metagenomics
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- University Hospital FreiburgUniversity, hospital or other
- Study start
- 11 Mar 2022 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 16 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Helicobacter pylori colonizes the stomach of about half of the world's population, including about 20-30% of adults in Germany. In some cases, this colonization can lead to chronic inflammation of the gastric mucosa, which can lead to various serious diseases such as ulcer disease and gastric cancer. It has been reported several times in the literature that Helicobacter pylori infection negatively affects the human intestinal flora and can lead to microbial imbalance (dysbiosis). Recent studies, mostly from mouse models, reveal new roles and interactions of the microbiome: host immune response may influence bacterial activity; bacterial metabolites may determine microbiome functions. Differences in the microbiome were also found between Helicobacter pylori-infected patients and were associated with treatment success. On the other hand, beneficial microbial symbiosis may prevent intestinal inflammation. The reasons for these differences in the microbiome of Helicobacter pylori-infected patients, which may also contribute to treatment failure, remain to be investigated. Therefore, this project aims to investigate how Helicobacter pylori affects the bacteria and fungi of the human gastrointestinal microbiome and how the suspected microbial imbalance may influence treatment success. In this project, The investigators aim to answer the question of how these newly discovered mechanisms alter the course of human H. pylori infection. The investigators will analyze H. pylori itself in colonized patients and asymptomatic individuals (whole genome sequencing), determine the immune response of the carrier (RNA expression in lymphocytes), and composition of the gut microbiome (DNA sequencing) and activity (RNA expression in the bacteria/fungi and identification of metabolites). Using bioinformatics approaches, particularly machine learning, The investigators will determine the parameters that predict disease progression and eradication success. The results will provide important decision support for H. pylori-infected patients.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Helicobacter pylori patients | – | Diagnostic Test: Analysis of gut microbiome and immune signaturesPatients with gastric biposies which was positive for Helicobacter pylori in culture |
| Helicobacter pylori asymptomatic carriers | – | Diagnostic Test: Analysis of gut microbiome and immune signaturesHealthy controls who are positive for Helicobacter pylori antigen in stool and have no symptoms of gastritis |
| Healthy controls | – | Diagnostic Test: Analysis of gut microbiome and immune signaturesHealthy controls who are negative for Helicobacter pylori antigen in stool and have no symptoms of gastritis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- 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: -
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Analysis of gut microbiome and immune signaturesThe 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. | Diagnostic test | Healthy controls, Helicobacter pylori asymptomatic carriers, Helicobacter pylori patients |
Primary outcome
Helicobacter pylori microbiome and immune signatures
Time frame: 12-18 Months
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.
1 secondary outcome
Helicobacter pylori eradication control
Time frame: 12-24 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Helicobacter Pylori Infection, run by University Hospital Freiburg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Tarek Badr, M.D. (00497612036585, mohamed.tarek.badr@uniklinik-freiburg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Helicobacter pylori microbiome and immune signatures (time frame: 12-18 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2024.