Irritable Bowel Syndrome Regional Cohort (COSII)

University Hospital, Rouen

Status: Enrolling

Conditions: Irritable Bowel Syndrome

Treatments: Other: unique collection of saddles; Other: self-questionnaires

Study type: Observational

Funder types: Other

Identifiers

NCT06900491

IDRCB : 2024-A02023-44 (Other Identifier)

2023/0143/OB

Details and patient eligibility

About

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.

Full 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.

Enrollment: 600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient
• Normal laboratory work-up as part of routine care (CBC, CRP)
• Over 18 years of age
• Patient affiliated to a social security scheme
• Person who has read and understood the information letter and does not object to taking part in the study

Exclusion criteria

• Patient suffering from an organic digestive pathology (chronic inflammatory bowel disease, microscopic colitis when endoscopy has been performed because deemed necessary, digestive cancer, coeliac disease) or major digestive surgery (excluding appendectomy and cholecystectomy).
• Patient refusal
• Patient does not speak or understand French
• A pregnant woman or a woman in labour or breastfeeding
• Person deprived of liberty by an administrative or judicial decision or person placed under court protection / sub- guardianship or curatorship

Trial design

600 participants in 1 patient group

Patients with irritable bowel syndrome

Description:

Patients with irritable bowel syndrome according to the Rome criteria in force at the time of inclusion (IV in 2024, V expected in 2025)

Treatment:

Other: self-questionnaires

Other: unique collection of saddles