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Recruiting NCT06900491

Irritable Bowel Syndrome Regional Cohort

— Observational Irritable Bowel Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: self-questionnaires, unique collection of saddles.
Who it may be relevant to
Registry conditions: Irritable Bowel Syndrome. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Development of a Regional Irritable Bowel Syndrome Cohort

Overview

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.

Interventions

  • 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

Primary outcome measures

  • Clinical prognostic factors for the disease (use of recreational substances) [Time frame: Visit V0 (inclusion)]
  • Clinical prognostic factors for the disease (clinical history) [Time frame: Visit V0 (inclusion)]
  • Clinical prognostic factors for the disease (use of treatment) [Time frame: Visit V0 (inclusion)]
  • Clinical prognostic factors for the disease (HAD score) [Time frame: Visit V0 (inclusion), Visits at 6 , 12, 18, 24, 30 and 36 months]
  • Evaluation of validated questionnaires (SCOFF-F questionnaire) [Time frame: Visit V0 (inclusion), Visits at 6 , 12, 18, 24, 30 and 36 months]
  • Evaluation of validated questionnaires (NIAS questionnaire (ARFID)) [Time frame: Visit V0 (inclusion), Visits at 6 , 12, 18, 24, 30 and 36 months]
  • Evaluation of validated questionnaires (Francis score) [Time frame: Visit V0 (inclusion), Visits at 6 , 12, 18, 24, 30 and 36 months]
  • Evaluation of validated questionnaires (GIQLI score) [Time frame: Visit V0 (inclusion), Visits at 6 , 12, 18, 24, 30 and 36 months]
  • Evaluation of validated questionnaires (Fear of food questionnaire) [Time frame: Visit V0 (inclusion), Visits at 6 , 12, 18, 24, 30 and 36 months]
  • Evaluation of validated questionnaires (EQ-5D-5L score) [Time frame: Visit V0 (inclusion), Visits at 6 , 12, 18, 24, 30 and 36 months]
Secondary outcome measures (2)
  • Metabolomic analyses [Time frame: Visit V0 (inclusion), Visits at 6 , 12, 18, 24, 30 and 36 months]
  • analyses carried out on stool samples (metagenomic shotgun) [Time frame: Visit V0 (inclusion), Visits at 6 , 12, 18, 24, 30 and 36 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 4 centers
  • University Hospitol of Amiens — Amiens
  • CHU de CAEN — Caen
  • University Hospital of Lille — Lille
  • University Rouen Hospital — Rouen

Identifiers

NCT: NCT06900491 · 2023/0143/OB · IDRCB : 2024-A02023-44

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗