Prevalence of Helicobacter Pylori on Patients With Chronic Inflammatory Bowel Disease (IBD) at the CHU of Guadeloupe (HP-MICI)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: HELICOBACTER PYLORI INFECTIONS; Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis)
• Intervention / Treatment: Other: Biopsies

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: georgette Saint-Georges, MD; Phone Number: +590 0590891445; Email: georgette.saint-georges@chu-guadeloupe.fr

Study Locations

• Guadeloupe
  • CHU de La Guadeloupe
    • Pointe-à-Pitre, CHU de La Guadeloupe, Guadeloupe, 97159
      • CHU de la Guadeloupe
      • Contact: Email: melanie.petapermal@chu-guadeloupe.fr
      • Contact: Mélanie Petapermal, Master degree; Phone Number: +590 0590934667; Email: melanie.petapermal@chu-guadeloupe.fr
      • Principal Investigator: georgette Saint-Georges, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At the time of endoscopic evaluation (baseline only).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	Baseline.

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de la Guadeloupe

Study record dates

Study Major Dates

• Study Start (Estimated): December 15, 2025
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): December 15, 2026

Study Registration Dates

• First Submitted: December 5, 2025
• First Submitted That Met QC Criteria: December 5, 2025
• First Posted (Actual): December 18, 2025

Study Record Updates

• Last Update Posted (Actual): December 18, 2025
• Last Update Submitted That Met QC Criteria: December 5, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Inflammatory Bowel Disease; intestinal microbioma; gastric microbioma; HELICOBACTER PYLORI INFECTIONS
• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Gastroenteritis; Colitis; Colitis, Ulcerative; Inflammatory Bowel Diseases; Investigative Techniques; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Surgical Procedures, Operative; Cytological Techniques; Cytodiagnosis; Diagnostic Techniques, Surgical; Biopsy
• Other Study ID Numbers: PAP_RIPH2_2025/01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No