Clinical trial NCT06900491: Irritable Bowel Syndrome Regional Cohort
Official title: Development of a Regional Irritable Bowel Syndrome Cohort
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Irritable Bowel Syndrome
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2025-03-28
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients suffering from IBS referred to our centres for treatment will be consecutively included in the cohort. Patients will be selected by all hepato-gastroenterologists.

Brief 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 2.5 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.

Eligibility criteria: 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

Primary outcomes:
measure: Clinical prognostic factors for the disease (use of recreational substances)
timeFrame: Visit V0 (inclusion)
measure: Clinical prognostic factors for the disease (clinical history)
timeFrame: Visit V0 (inclusion)
measure: Clinical prognostic factors for the disease (use of treatment)
timeFrame: Visit V0 (inclusion)
measure: Clinical prognostic factors for the disease (HAD score)
timeFrame: Visit V0 (inclusion)
measure: Evaluation of validated questionnaires (SCOFF-F questionnaire)
timeFrame: Visit V0 (inclusion), Visits at 6 , 12, 18, 24, 30 and 36 months
measure: Evaluation of validated questionnaires (NIAS questionnaire (ARFID))
timeFrame: Visit V0 (inclusion), Visits at 6 , 12, 18, 24, 30 and 36 months
measure: Evaluation of validated questionnaires (Francis score)
timeFrame: Visit V0 (inclusion), Visits at 6 , 12, 18, 24, 30 and 36 months
measure: Evaluation of validated questionnaires (GIQLI score)
timeFrame: Visit V0 (inclusion), Visits at 6 , 12, 18, 24, 30 and 36 months
measure: Evaluation of validated questionnaires (Fear of food questionnaire)
timeFrame: Visit V0 (inclusion), Visits at 6 , 12, 18, 24, 30 and 36 months
measure: Evaluation of validated questionnaires (EQ-5D-5L score)
timeFrame: Visit V0 (inclusion), Visits at 6 , 12, 18, 24, 30 and 36 months
measure: Clinical prognostic factors for the disease (medical interview)
timeFrame: Visit V0 (inclusion)
measure: Clinical prognostic factors for the disease (Food avoidance questionnaire/exclusion diet)
timeFrame: Visit V0 (inclusion)
Secondary outcomes:
measure: analyses carried out on stool samples (microbiota)
timeFrame: Visit V0 (inclusion), Visits at 6 , 12, 18, 24, 30 and 36 months
measure: analyses carried out on stool samples (metagenomic shotgun)
timeFrame: Visit V0 (inclusion), Visits at 6 , 12, 18, 24, 30 and 36 months
Other outcomes:
Locations:
city: Amiens
country: France
facility: University Hospitol of Amiens
city: Lille
country: France
facility: University Hospital of Lille
city: Montivilliers
country: France
facility: Groupe Hospitalier du Havre
city: Rouen
country: France
facility: University Rouen Hospital
Study officials:
References: