Irritable Bowel Syndrome Regional Cohort (COSII)

Development of a Regional Irritable Bowel Syndrome Cohort

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.

Study Overview

• Status: Recruiting
• Conditions: Irritable Bowel Syndrome
• Intervention / Treatment: Other: self-questionnaires; Other: unique collection of saddles

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.

• Study Type: Observational
• Enrollment (Estimated): 600

Contacts and Locations

• Study Contact: Name: David DM MALLET, Director; Phone Number: +33 02 32 88 82 65; Email: david.mallet@chu-rouen.fr
• Study Contact Backup: Name: Vincent VF FERRANTI, ARC; Phone Number: +33 0232888265; Email: vincent.ferranti@chu-rouen.fr

Study Locations

• France
  • Amiens, France, 80000
    • Not yet recruiting
    • University Hospitol of Amiens
    • Contact: Mathurin MF FUMERY, Professor; Email: Fumery.Mathurin@chu-amiens.fr
  • Caen, France, 14033
    • Not yet recruiting
    • CHU de Caen
    • Contact: Oumniya OA ARJAFALLAH GOULET, Professor; Phone Number: +33 02 31 06 45 43; Email: arjafallah-o@chu-caen.mssante.fr
  • Lille, France, 59037
    • Not yet recruiting
    • University Hospital of Lille
    • Contact: Pauline PW WILS, Doctor; Email: pauline.wils@chu-lille.fr
  • Rouen, France, 76031
    • Recruiting
    • University Rouen Hospital
    • Contact: Chloé CM MELCHIOR, Professor; Phone Number: +33 0232888990; Email: chloe.melchior@chu-rouen.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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)

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical prognostic factors for the disease (use of recreational substances)	Assessing the use of amphetamines, LSD, cannabis, marijuana, heroin, cocaine, ecstasy, ketamine and methadone	Visit V0 (inclusion)
Clinical prognostic factors for the disease (clinical history)	Assessment of antecedents: appendectomy, cholecystectomy, digestive surgery, diabetes and co-morbidities: fibromyalgia, chronic fatigue syndrome, migraine, hypermobility syndrome or Ehlers Danlos, eating disorders, ARFID, endometriosis or adenomyosis, insomnia and sleep disorders.	Visit V0 (inclusion)
Clinical prognostic factors for the disease (use of treatment)	Assessment of the patient's use of probiotics, antispasmodics, analgesics, morphine, transit slowers, laxatives, psychiatric treatments, diets and alternative treatments.	Visit V0 (inclusion)
Evaluation of validated questionnaires (SCOFF-F questionnaire)	Evaluation of patient responses to the SCOFF-F questionnaire (medical interview on weight loss or gain),	Visit V0 (inclusion), Visits at 6 , 12, 18, 24, 30 and 36 months
Evaluation of validated questionnaires (NIAS questionnaire (ARFID))	Evaluation of patient responses to the NIAS questionnaire (ARFID) (Evaluation of food intake restriction or avoidance disorder: clinical characteristics characteristics ),	Visit V0 (inclusion), Visits at 6 , 12, 18, 24, 30 and 36 months
Evaluation of validated questionnaires (Francis score)	Evaluation of patient responses to the Francis score (Assessment of symptoms associated with irritable bowel syndrome (score from 0 to 500), the higher the score, the more severe the disease),	Visit V0 (inclusion), Visits at 6 , 12, 18, 24, 30 and 36 months
Evaluation of validated questionnaires (GIQLI score)	Evaluation of patient responses to the GIQLI score (Digestive quality of life score comprising 36 items covering symptoms, physical status, emotions, social problems and the effect of medical treatments. The score ranges from 0 to 144; the higher the score, the better the quality of life).	Visit V0 (inclusion), Visits at 6 , 12, 18, 24, 30 and 36 months
Evaluation of validated questionnaires (Fear of food questionnaire)	Evaluation of patient responses to the Fear of food questionnaire (The Fear of Food Questionnaire (FFQ) is an 18-item self-report questionnaire that measures fear, avoidance of food, as well as life interference and loss of pleasure from eating. Items are rated on a Likert scale ranging from 0 (not at all) to 5 (absolutely). Qualitative score ranges are 0-15 (minimal), 16-30 (mild), 31-45 (moderate), and 46-90 (severe))	Visit V0 (inclusion), Visits at 6 , 12, 18, 24, 30 and 36 months
Evaluation of validated questionnaires (EQ-5D-5L score)	Evaluation of patient responses to the EQ-5D-5L score (The EQ-5D-5L1 questionnaire is a European quality of life scale. The first part contains questions known as the 'EQ-5D descriptive system', supplemented by a visual analogue scale known as the 'EQ-5D VAS'. It consists of a 20 cm, graduated from 0 to 100, on which the patient is asked to indicate how they rate their current state of health, with 0 being the worst possible state and 100 being the best. and 100 being the best.).	Visit V0 (inclusion), Visits at 6 , 12, 18, 24, 30 and 36 months
Clinical prognostic factors for the disease (medical interview)	Assessment of sexual or physical aggression (medical interview), post-infectious nature (medical interview)	Visit V0 (inclusion)
Clinical prognostic factors for the disease (HAD score)	Assessment of stress (HAD score : Hospital Anxiety and depression scale (score ranging from 0 to 21)	Visit V0 (inclusion), Visits at 6 , 12, 18, 24, 30 and 36 months
Clinical prognostic factors for the disease (Food avoidance questionnaire/exclusion diet)	Assessment of link with diet (Food avoidance questionnaire/exclusion diet informations)	Visit V0 (inclusion), Visits at 6 , 12, 18, 24, 30 and 36 months
Evaluation of validated questionnaires (VSI Score)	A standardized psychological questionnaire that assesses coping strategies, that is, how a person deals with stress. 15 items describe a possible reaction to stress. For each of the 15 items, the person indicates to what extent the described reaction corresponds to them when they are stressed (in the face of pain, constipation, bloating, or an urgent need to go to the toilet). Six rating scales are used, ranging from: 1 strongly agree, 2 somewhat agree, 3 slightly agree, 4 slightly disagree, 5 somewhat disagree, and 6 strongly disagree	Visit V0 (inclusion), Visits at 6 , 12, 18, 24, 30 and 36 months
Evaluation of validated questionnaires (PHQ15 Score)	Screening for somatic symptoms (frequent physical complaints). 15 items corresponding to a physical symptom. 3 levels of response: score 0 means no somatic symptoms, score 1 means mild somatic symptoms, and score 2 means severe somatic symptoms	Visit V0 (inclusion), Visits at 6 , 12, 18, 24, 30 and 36 months
Evaluation of validated questionnaires (CISS)	This assessment evaluates an individual's cognitive and behavioral efforts to manage a situation perceived as stressful. Seven items, each worth 5 points, assess a single coping style (minimum score of 7 and maximum of 28). A low score indicates limited cognitive and behavioral effort in managing a situation perceived as stressful.	Visit V0 (inclusion), Visits at 6 , 12, 18, 24, 30 and 36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
analyses carried out on stool samples (metagenomic shotgun)	metagenomic shotgun analysis of microbiota (composition of the microbiota)	Visit V0 (inclusion), Visits at 6 , 12, 18, 24, 30 and 36 months
Metabolomic analyses	Metabolomics by GC-MS and LC-MS, lipidomics, SCFAs, bile acids	Visit V0 (inclusion), Visits at 6 , 12, 18, 24, 30 and 36 months

Collaborators and Investigators

• Sponsor: University Hospital, Rouen

Study record dates

Study Major Dates

• Study Start (Actual): March 4, 2025
• Primary Completion (Estimated): September 4, 2030
• Study Completion (Estimated): September 4, 2030

Study Registration Dates

• First Submitted: March 14, 2025
• First Submitted That Met QC Criteria: March 27, 2025
• First Posted (Actual): March 28, 2025

Study Record Updates

• Last Update Posted (Actual): January 8, 2026
• Last Update Submitted That Met QC Criteria: January 6, 2026
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Colonic Diseases, Functional; Irritable Bowel Syndrome
• Other Study ID Numbers: 2023/0143/OB; IDRCB : 2024-A02023-44 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The data provided will be the property of the sponsor and will be used solely for its own research activities.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No