Irritable Bowel Syndrome Regional Cohort

NCT06900491 | Recruiting

• 2 other identifiers: 2023/0143/OBIDRCB : 2024-A02023-44
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 4

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.

Conditions

Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (15)

• 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)

• 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

• 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 (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 Outcomes (2)

• Metabolomic analyses

  Visit V0 (inclusion), Visits at 6 , 12, 18, 24, 30 and 36 months

• analyses carried out on stool samples (metagenomic shotgun)

  Visit V0 (inclusion), Visits at 6 , 12, 18, 24, 30 and 36 months

Study Arms (1)

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; Other: unique collection of saddles

Interventions

self-questionnaires 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.

Patients with irritable bowel syndrome

unique collection of saddles OTHER

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

Patients with irritable bowel syndrome

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (4)

University Hospitol of Amiens

Amiens, 80000, France

NOT YET RECRUITING

CHU de CAEN

Caen, 14033, France

NOT YET RECRUITING

University Hospital of Lille

Lille, 59037, France

NOT YET RECRUITING

University Rouen Hospital

Rouen, 76031, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

The aim of setting up this biological collection is to be able to analyse the microbiota and the metabolites produced longitudinally. There will be a unique collection of saddles

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Central Study Contacts

David DM MALLET, Director

CONTACT

02 32 88 82 65; david.mallet@chu-rouen.fr

Vincent VF FERRANTI, ARC

CONTACT

0232888265; vincent.ferranti@chu-rouen.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2025
• First Posted: March 28, 2025
• Study Start: March 4, 2025
• Primary Completion (Estimated): September 4, 2030
• Study Completion (Estimated): September 4, 2030
• Last Updated: January 8, 2026

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4)