Irritable Bowel Syndrome Regional Cohort

Last updated: March 27, 2025
Sponsor: University Hospital, Rouen
Overall Status: Active - Recruiting

Phase

N/A

Condition

Colic

Gastrointestinal Diseases And Disorders

Lactose Intolerance

Treatment

unique collection of saddles

self-questionnaires

Clinical Study ID

NCT06900491
2023/0143/OB
IDRCB : 2024-A02023-44
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 totaking part in the study

Exclusion

Exclusion Criteria:

  • Patient suffering from an organic digestive pathology (chronic inflammatory boweldisease, microscopic colitis when endoscopy has been performed because deemednecessary, digestive cancer, coeliac disease) or major digestive surgery (excludingappendectomy 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 personplaced under court protection / sub- guardianship or curatorship

Study Design

Total Participants: 600
Treatment Group(s): 2
Primary Treatment: unique collection of saddles
Phase:
Study Start date:
March 04, 2025
Estimated Completion Date:
March 04, 2030

Study 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.

Connect with a study center

  • University Hospitol of Amiens

    Amiens, 80000
    France

    Site Not Available

  • University Hospital of Lille

    Lille, 59037
    France

    Site Not Available

  • Groupe Hospitalier du Havre

    Montivilliers, 76290
    France

    Site Not Available

  • University Rouen Hospital

    Rouen, 76031
    France

    Active - Recruiting

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