NCT07292454

Brief 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 Helicobacter pylori (H. pylori) in the stomach.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
7mo left

Started Dec 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress39%
Dec 2025Dec 2026

First Submitted

Initial submission to the registry

December 5, 2025

Completed
10 days until next milestone

Study Start

First participant enrolled

December 15, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 18, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2026

Last Updated

December 18, 2025

Status Verified

December 1, 2025

Enrollment Period

1 year

First QC Date

December 5, 2025

Last Update Submit

December 5, 2025

Conditions

Keywords

intestinal microbiomagastric microbiomaHELICOBACTER PYLORI INFECTIONSInflammatory Bowel Disease

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Demographic characteristics according to H. pylori infection status

    Baseline.

  • Clinical characteristics according to H. pylori infection status

    Baseline.

  • Biological inflammatory markers according to H. pylori infection status

    Baseline.

  • IBD-related treatments according to H. pylori infection status

    Baseline.

  • Prevalence of gastric intestinal metaplasia and dysplasia according to H. pylori infection status

    Baseline.

  • +1 more secondary outcomes

Study Arms (1)

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

Interventions

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.

Patients with Inflammatory Bowel Disease

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may not qualify if:

  • Patients of less than18 years Patients having not given their writing informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de la Guadeloupe

Pointe-à-Pitre, CHU de La Guadeloupe, 97159, Guadeloupe

Location

MeSH Terms

Conditions

Inflammatory Bowel DiseasesColitis, Ulcerative

Interventions

Biopsy

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesColitisColonic Diseases

Intervention Hierarchy (Ancestors)

CytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingDiagnostic Techniques, SurgicalSurgical Procedures, OperativeInvestigative Techniques

Central Study Contacts

georgette Saint-Georges, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 5, 2025

First Posted

December 18, 2025

Study Start

December 15, 2025

Primary Completion (Estimated)

December 15, 2026

Study Completion (Estimated)

December 15, 2026

Last Updated

December 18, 2025

Record last verified: 2025-12

Locations