Irritable Bowel Syndrome Regional Cohort (COSII)

January 6, 2026 updated by: University Hospital, Rouen

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Amiens, France, 80000
      • Caen, France, 14033
      • Lille, France, 59037
      • Rouen, France, 76031
        • Recruiting
        • University Rouen Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Clinical prognostic factors for the disease (use of recreational substances)
Time Frame: Visit V0 (inclusion)
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)
Time Frame: Visit V0 (inclusion)
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)
Time Frame: Visit V0 (inclusion)
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)
Time Frame: Visit V0 (inclusion), Visits at 6 , 12, 18, 24, 30 and 36 months
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))
Time Frame: Visit V0 (inclusion), Visits at 6 , 12, 18, 24, 30 and 36 months
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)
Time Frame: Visit V0 (inclusion), Visits at 6 , 12, 18, 24, 30 and 36 months
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)
Time Frame: Visit V0 (inclusion), Visits at 6 , 12, 18, 24, 30 and 36 months
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)
Time Frame: Visit V0 (inclusion), Visits at 6 , 12, 18, 24, 30 and 36 months
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)
Time Frame: Visit V0 (inclusion), Visits at 6 , 12, 18, 24, 30 and 36 months
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)
Time Frame: Visit V0 (inclusion)
Assessment of sexual or physical aggression (medical interview), post-infectious nature (medical interview)
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
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)
Time Frame: Visit V0 (inclusion), Visits at 6 , 12, 18, 24, 30 and 36 months
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)
Time Frame: Visit V0 (inclusion), Visits at 6 , 12, 18, 24, 30 and 36 months
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)
Time Frame: Visit V0 (inclusion), Visits at 6 , 12, 18, 24, 30 and 36 months
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)
Time Frame: Visit V0 (inclusion), Visits at 6 , 12, 18, 24, 30 and 36 months
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
analyses carried out on stool samples (metagenomic shotgun)
Time Frame: Visit V0 (inclusion), Visits at 6 , 12, 18, 24, 30 and 36 months
metagenomic shotgun analysis of microbiota (composition of the microbiota)
Visit V0 (inclusion), Visits at 6 , 12, 18, 24, 30 and 36 months
Metabolomic analyses
Time Frame: Visit V0 (inclusion), Visits at 6 , 12, 18, 24, 30 and 36 months
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Rouen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 4, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 4, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 4, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 14, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 27, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 28, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 8, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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