HELICOBACTER PYLORI INFECTIONSHP-MICINCT07292454
Prevalence of Helicobacter Pylori on Patients With Chronic Inflammatory Bowel Disease (IBD) at the CHU of Guadeloupe
An observational study of HELICOBACTER PYLORI INFECTIONS and Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis), run by Centre Hospitalier Universitaire de la Guadeloupe at 1 site in Guadeloupe.
Trial summary
Clinical and experimental data suggest that dysbiosis may play a pivotal role in the pathogenesis of intestinal bowel disease (IBD). However, to the best of our knowledge, the composition of gastric and of intestinal microbiome has never been investigated in a population with IBD according to the presence/absence of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HELICOBACTER PYLORI INFECTIONS, Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis)
- What is being tested?
- Biopsies
- How many people
- 100 participants
- Where
- 1 siteGuadeloupe
- Study dates
- 15 Dec 2025to 15 Dec 2026
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with a confirmed diagnosis of Inflammatory Bowel Disease (Crohn's disease or ulcerative colitis) receiving routine follow-up care at the University Hospital of Guadeloupe. All participants are scheduled to undergo an upper gastrointestinal endoscopy as part of standard clinical management.
Who may be able to join
- Patients over 18 years old Patients with IBD from the CHU of Guadeloupe Patients benefiting from an investigation of H. pylori infection through gastric biopsies and/or serology at the time of diagnosis of IBD Patients affiliated to the French social security system Free informed and written consent signed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research)
Who cannot join
- Patients of less than18 years Patients having not given their writing informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Guadeloupe1 site
CHU de la Guadeloupe
Pointe-à-Pitre, CHU de La Guadeloupe, 97159
Mélanie Petapermal, Master degree, 0590934667 ext. +590, melanie.petapermal@chu-guadeloupe.fr
melanie.petapermal@chu-guadeloupe.fr
About this study
Clinical and experimental data suggest that dysbiosis may play a pivotal role in the pathogenesis of intestinal bowel disease (IBD). However, to the best of our knowledge, the composition of gastric and of intestinal microbiome has never been investigated in a population with IBD according to the presence/absence of Helicobacter pylori (H. pylori) in the stomach.
Read the detailed description
- pylori infection is one of the most widely spread infectious diseases in humans. Although the pathogenesis of IBD is unknown, this pathology could result from complex interactions between environmental factors and the intestinal microbiota, with dysbiosis likely being a key factor. In theory, H. pylori infection could be involved in the pathogenesis of IBD by inducing alterations in gastric and/or intestinal permeability or by causing immunological derangements. However, various studies indicate that the prevalence of H. pylori infection is low in patients with IBD, suggesting a protective role for this infection in the development of IBD.
The objective of the study is to investigate the potential link between H. pylori infection and IBD. Another objective is to analyze the complex interactions between the gastric and intestinal microbiome in a population with IBD according to the presence or absence of H. pylori in the stomach.
The study will be based on a prospective cohort of patients with IBD receiving medical care at the CHU of Guadeloupe.
- Conditions
- HELICOBACTER PYLORI INFECTIONS, Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis)
- Being tested
- Biopsies
- Keywords
- intestinal microbioma, gastric microbioma, HELICOBACTER PYLORI INFECTIONS, Inflammatory Bowel Disease
- Medical subject headings
- Inflammatory Bowel Diseases, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiopsiesOther
Gastric biopsies are taken during digestive endoscopy as part of routine clinical care. Two additional biopsies (one fundic and one antral) are planned for research purposes, specifically for metagenomic analysis of the gastric microbiome.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Inflammatory Bowel Disease | Endoscopy is systematically performed in patients with Inflammatory Bowel Disease (IBD). In accordance with the recommendations of the French National Authority for Health, gastric biopsies are taken during digestive endoscopy as part of routine clinical care. Two additional biopsies (one fundic and one antral) are planned for research purposes, specifically for metagenomic analysis of the gastric microbiome. Receives: Other: Biopsies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of H. pylori infection in patients with Inflammatory Bowel Disease (IBD)
Presence of Helicobacter pylori infection determined using gastric biopsies collected during clinically indicated upper gastrointestinal endoscopy. Infection status will be confirmed by standard histological assessment performed as part of routine care. The prevalence will be expressed as the proportion of IBD patients with confirmed H. pylori infection among all included IBD patients in the cohort.
Measured: At the time of endoscopic evaluation (baseline only).
Secondary outcomes (6)
Demographic characteristics according to H. pylori infection status
Comparison of demographic characteristics (age, sex, ethnicity) between IBD patients with and without confirmed H. pylori infection. Data collected at baseline from medical records.
Measured: Baseline.
Clinical characteristics according to H. pylori infection status
Comparison of clinical characteristics (type of IBD, disease duration, clinical activity) between IBD patients with and without confirmed H. pylori infection. Data collected at baseline from medical records.
Measured: Baseline.
Biological inflammatory markers according to H. pylori infection status
Comparison of biological markers related to disease activity (e.g., C-reactive protein, fecal calprotectin) between IBD patients with and without confirmed H. pylori infection.
Measured: Baseline.
IBD-related treatments according to H. pylori infection status
Comparison of ongoing therapeutic regimens (e.g., immunosuppressants, biologics, corticosteroids) between IBD patients with and without confirmed H. pylori infection.
Measured: Baseline.
Prevalence of gastric intestinal metaplasia and dysplasia according to H. pylori infection status
Histological assessment of gastric biopsies to determine intestinal metaplasia or dysplasia, compared between groups with/without H. pylori.
Measured: Baseline.
Composition of the gastric microbiome according to H. pylori infection status
Metagenomic analysis of additional gastric biopsies (fundic + antral) to compare microbiome profiles between IBD patients with and without H. pylori.
Measured: Baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2025
- Study start15 Dec 2025 (estimated)
- Primary completion15 Dec 2026 (estimated)
- Study completion15 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HELICOBACTER PYLORI INFECTIONSStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de la Guadeloupe
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07292454
- Sponsor's protocol ID
- PAP_RIPH2_2025/01
- Acronym
- HP-MICI
- Status last verified
- Dec 2025
- First submitted
- 5 Dec 2025
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Helicobacter Pylori on Patients With Chronic Inflammatory Bowel Disease (IBD) at the CHU of Guadeloupe
- ClinicalTrials.gov ID
- NCT07292454
- Acronym / sponsor ID
- HP-MICI / PAP_RIPH2_2025/01
- Conditions
- HELICOBACTER PYLORI INFECTIONS, Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis)
- Keywords
- intestinal microbioma, gastric microbioma, HELICOBACTER PYLORI INFECTIONS, Inflammatory Bowel Disease
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de la GuadeloupeUniversity, hospital or other
- Study start
- 15 Dec 2025 (estimated)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 18 Dec 2025 (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.
Clinical and experimental data suggest that dysbiosis may play a pivotal role in the pathogenesis of intestinal bowel disease (IBD). However, to the best of our knowledge, the composition of gastric and of intestinal microbiome has never been investigated in a population with IBD according to the presence/absence of Helicobacter pylori (H. pylori) in the stomach.
Detailed description
- pylori infection is one of the most widely spread infectious diseases in humans. Although the pathogenesis of IBD is unknown, this pathology could result from complex interactions between environmental factors and the intestinal microbiota, with dysbiosis likely being a key factor. In theory, H. pylori infection could be involved in the pathogenesis of IBD by inducing alterations in gastric and/or intestinal permeability or by causing immunological derangements. However, various studies indicate that the prevalence of H. pylori infection is low in patients with IBD, suggesting a protective role for this infection in the development of IBD.
The objective of the study is to investigate the potential link between H. pylori infection and IBD. Another objective is to analyze the complex interactions between the gastric and intestinal microbiome in a population with IBD according to the presence or absence of H. pylori in the stomach.
The study will be based on a prospective cohort of patients with IBD receiving medical care at the CHU of Guadeloupe.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Inflammatory Bowel Disease | – | Other: BiopsiesEndoscopy is systematically performed in patients with Inflammatory Bowel Disease (IBD). In accordance with the recommendations of the French National Authority for Health, gastric biopsies are taken during digestive endoscopy as part of routine clinical care. Two additional biopsies (one fundic and one antral) are planned for research purposes, specifically for metagenomic analysis of the gastric microbiome. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with a confirmed diagnosis of Inflammatory Bowel Disease (Crohn's disease or ulcerative colitis) receiving routine follow-up care at the University Hospital of Guadeloupe. All participants are scheduled to undergo an upper gastrointestinal endoscopy as part of standard clinical management.
Key inclusion criteria (1 listed)
- Patients over 18 years old Patients with IBD from the CHU of Guadeloupe Patients benefiting from an investigation of H. pylori infection through gastric biopsies and/or serology at the time of diagnosis of IBD Patients affiliated to the French social security system Free informed and written consent signed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research)
Key exclusion criteria (1 listed)
- Patients of less than18 years Patients having not given their writing informed consent
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 |
|---|---|---|
| BiopsiesGastric biopsies are taken during digestive endoscopy as part of routine clinical care. Two additional biopsies (one fundic and one antral) are planned for research purposes, specifically for metagenomic analysis of the gastric microbiome. | Other | Patients with Inflammatory Bowel Disease |
Primary outcome
Prevalence of H. pylori infection in patients with Inflammatory Bowel Disease (IBD)
Time frame: At the time of endoscopic evaluation (baseline only).
Presence of Helicobacter pylori infection determined using gastric biopsies collected during clinically indicated upper gastrointestinal endoscopy. Infection status will be confirmed by standard histological assessment performed as part of routine care. The prevalence will be expressed as the proportion of IBD patients with confirmed H. pylori infection among all included IBD patients in the cohort.
6 secondary outcomes
Demographic characteristics according to H. pylori infection status
Time frame: Baseline.
Clinical characteristics according to H. pylori infection status
Time frame: Baseline.
Biological inflammatory markers according to H. pylori infection status
Time frame: Baseline.
IBD-related treatments according to H. pylori infection status
Time frame: Baseline.
Prevalence of gastric intestinal metaplasia and dysplasia according to H. pylori infection status
Time frame: Baseline.
Composition of the gastric microbiome according to H. pylori infection status
Time frame: Baseline.
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 18 Dec 2025.
- Individual participant dataSharing planned: Undecided
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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 INFECTIONS and Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis), run by Centre Hospitalier Universitaire de la Guadeloupe at 1 site in Guadeloupe.
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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 18 Dec 2025. 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 Guadeloupe. 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 georgette Saint-Georges, MD (0590891445 ext. +590, georgette.saint-georges@chu-guadeloupe.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of H. pylori infection in patients with Inflammatory Bowel Disease (IBD) (time frame: At the time of endoscopic evaluation (baseline only).). 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 18 Dec 2025.