An observational study in HELICOBACTER PYLORI INFECTIONS and Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis), sponsored by Centre Hospitalier Universitaire de la Guadeloupe. Not yet recruiting at 1 site in Guadeloupe. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-18.
Sponsored by Centre Hospitalier Universitaire de la Guadeloupe · Observational
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.
H. 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.
1,853 studies on the registry are indexed under Colitis, Ulcerative; 472 are open to participants now.
This study's planned enrollment of 100 is below the median of 198 across 551 observational studies indexed under Colitis, Ulcerative.
Browse Colitis, Ulcerative studies →Centre Hospitalier Universitaire de la Guadeloupe is the lead sponsor of 50 studies on the registry; 25 are open to participants now.
Compared within Colitis, Ulcerative, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Inflammatory Bowel Diseases. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients over 18 years old Patients with IBD from the CHU of Guadeloupe Patients benefiting from an investigation of H. pylori infection through gastric 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)
Exclusion Criteria:
Patients of less than18 years Patients having not given their writing
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: Biopsies
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.
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.
Time frame: At the time of endoscopic evaluation (baseline only).
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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Centre Hospitalier Universitaire de la Guadeloupe