CHU de la Guadeloupe
Pointe-à-Pitre, CHU de La Guadeloupe, 97159, Guadeloupe
Location contact
Mélanie Petapermal, Master degree
CONTACT
0590934667 ext. +590
georgette Saint-Georges, MD
PRINCIPAL_INVESTIGATOR
CONTACT
NCT Number: NCT07292454
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Observational
Pointe-à-Pitre, CHU de La Guadeloupe, 97159, Guadeloupe
Mélanie Petapermal, Master degree
CONTACT
0590934667 ext. +590
georgette Saint-Georges, MD
PRINCIPAL_INVESTIGATOR
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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)
Exclusion criteria
Patients of less than18 years Patients having not given their writing informed consent
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.
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.
Time frame: Baseline.
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.
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.
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.
Comparison of ongoing therapeutic regimens (e.g., immunosuppressants, biologics, corticosteroids) between IBD patients with and without confirmed H. pylori infection.
Time frame: Baseline.
Histological assessment of gastric biopsies to determine intestinal metaplasia or dysplasia, compared between groups with/without H. pylori.
Time frame: Baseline.
Metagenomic analysis of additional gastric biopsies (fundic + antral) to compare microbiome profiles between IBD patients with and without H. pylori.
Contact information is provided by the study sponsor or research team.
Centre Hospitalier Universitaire de la Guadeloupe
Other
Acronym: HP-MICI
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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