NCT06900491

Irritable Bowel Syndrome Regional Cohort

Development of a Regional Irritable Bowel Syndrome Cohort

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 600 (estimated)
• Sponsor: University Hospital, Rouen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Setting up a regional (multicentre), longitudinal cohort of people suffering from irritable bowel syndrome followed up in consultation to study the natural history of the disease and its prognosis.

Detailed description

The strategy of this project is to develop a regional cohort of patients suffering from irritable bowel syndrome, in order to offer harmonised phenotyping, longitudinal follow-up and the study of clinical and biological factors associated with the development of the disease and its treatment. To achieve this, the study plans to prospectively collect a complete phenotyping of patients suffering from IBS and followed up in consultation in the participating centres (questioning, questionnaires, physiological explorations and results of complementary examinations), with follow-up of the course of the disease and which will be supplemented by stool samples for analyses of the microbiota and metabolites. The study aims to include all patients seen prospectively in the centres over a period of 3 years and to include as many stool samples as possible during follow-up visits. This should make it possible to include a total of 600 patients. This number will be sufficient to identify subgroups of patients with similar clinical or biological characteristics of reasonable size (at least 50 to 100 subjects each) and then compare their prognosis.

Conditions

• Irritable Bowel Syndrome

Interventions

Type	Name	Description
OTHER	self-questionnaires	Patients will fill in these self-questionnaires on a tablet or on paper, depending on the availability of tablets in the centres, before and after consulting the doctor. These questionnaires assess the severity of the disease and quality of life.
OTHER	unique collection of saddles	Stool samples will be taken at each visit, i.e. approximately every 6 months for patients

Timeline

• Start date: 2025-03-04
• Primary completion: 2030-09-04
• Completion: 2030-09-04
• First posted: 2025-03-28
• Last updated: 2026-01-08

Locations

4 sites across 1 country: France