Irritable Bowel Syndrome Regional Cohort

NCT ID: NCT06900491

Last Updated: 2026-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-03-04

Study Completion Date

2030-09-04

Brief Summary

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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

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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

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Irritable Bowel Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with irritable bowel syndrome

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

self-questionnaires

Intervention Type OTHER

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.

unique collection of saddles

Intervention Type OTHER

Stool samples will be taken at each visit, i.e. approximately every 6 months for patients

Interventions

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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.

Intervention Type OTHER

unique collection of saddles

Stool samples will be taken at each visit, i.e. approximately every 6 months for patients

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Rouen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University Hospitol of Amiens

Amiens, , France

Site Status NOT_YET_RECRUITING

CHU de CAEN

Caen, , France

Site Status NOT_YET_RECRUITING

University Hospital of Lille

Lille, , France

Site Status NOT_YET_RECRUITING

University Rouen Hospital

Rouen, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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David DM MALLET, Director

Role: CONTACT

02 32 88 82 65 ext. +33

Vincent VF FERRANTI, ARC

Role: CONTACT

0232888265 ext. +33

Facility Contacts

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Mathurin MF FUMERY, Professor

Role: primary

Oumniya OA ARJAFALLAH GOULET, Professor

Role: primary

02 31 06 45 43 ext. +33

Pauline PW WILS, Doctor

Role: primary

ChloƩ CM MELCHIOR, Professor

Role: primary

0232888990 ext. +33

Other Identifiers

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IDRCB : 2024-A02023-44

Identifier Type: OTHER

Identifier Source: secondary_id

2023/0143/OB

Identifier Type: -

Identifier Source: org_study_id

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