Irritable Bowel SyndromeCOSIINCT06900491
Irritable Bowel Syndrome Regional Cohort
An observational study of Irritable Bowel Syndrome, run by University Hospital, Rouen at 4 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- self-questionnaires and unique collection of saddles
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 600 participants
- Where
- 4 sitesFrance
- Study dates
- 4 Mar 2025to 4 Sep 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France4 sites, 4 recruiting
- Not yet recruiting
University Hospitol of Amiens
Amiens, 80000
Mathurin MF FUMERY, Professor, Fumery.Mathurin@chu-amiens.fr
- Not yet recruiting
CHU de CAEN
Caen, 14033
Oumniya OA ARJAFALLAH GOULET, Professor, 02 31 06 45 43 ext. +33, arjafallah-o@chu-caen.mssante.fr
- Not yet recruiting
University Hospital of Lille
Lille, 59037
Pauline PW WILS, Doctor, pauline.wils@chu-lille.fr
- Recruiting
University Rouen Hospital
Rouen, 76031
Chloé CM MELCHIOR, Professor, 0232888990 ext. +33, chloe.melchior@chu-rouen.fr
About this study
Official title: 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.
Read the 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.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- self-questionnaires, unique collection of saddles
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
self-questionnairesOther
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.
unique collection of saddlesOther
Stool samples will be taken at each visit, i.e. approximately every 6 months for patients
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Other: self-questionnaires; Other: unique collection of saddles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical prognostic factors for the disease (use of recreational substances)
Assessing the use of amphetamines, LSD, cannabis, marijuana, heroin, cocaine, ecstasy, ketamine and methadone
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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),
Measured: 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 ),
Measured: 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),
Measured: 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).
Measured: 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))
Measured: 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.).
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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.
Measured: Visit V0 (inclusion), Visits at 6 , 12, 18, 24, 30 and 36 months
Secondary outcomes (2)
Metabolomic analyses
Metabolomics by GC-MS and LC-MS, lipidomics, SCFAs, bile acids
Measured: Visit V0 (inclusion), Visits at 6 , 12, 18, 24, 30 and 36 months
analyses carried out on stool samples (metagenomic shotgun)
metagenomic shotgun analysis of microbiota (composition of the microbiota)
Measured: Visit V0 (inclusion), Visits at 6 , 12, 18, 24, 30 and 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2025
- Study start4 Mar 2025
- Primary completion4 Sep 2030 (estimated)
- Study completion4 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06900491
- Sponsor's protocol ID
- 2023/0143/OB
- Other IDs
- IDRCB : 2024-A02023-44
- Acronym
- COSII
- Status last verified
- Mar 2025
- First submitted
- 14 Mar 2025
- Last updated
- 8 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data provided will be the property of the sponsor and will be used solely for its own research activities.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Regional Irritable Bowel Syndrome Cohort
- ClinicalTrials.gov ID
- NCT06900491
- Acronym / sponsor ID
- COSII / 2023/0143/OB
- Conditions
- Irritable Bowel Syndrome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 4 Mar 2025 (actual)
- Primary completion
- 4 Sep 2030 (estimated)
- Study completion
- 4 Sep 2030 (estimated)
- First posted
- 28 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with irritable bowel syndrome | – | Other: self-questionnaires, Other: unique collection of saddlesPatients with irritable bowel syndrome according to the Rome criteria in force at the time of inclusion (IV in 2024, V expected in 2025) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| self-questionnairesPatients 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 | Patients with irritable bowel syndrome |
| unique collection of saddlesStool samples will be taken at each visit, i.e. approximately every 6 months for patients | Other | Patients with irritable bowel syndrome |
Primary outcome
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
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.
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.
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)
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),
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 ),
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),
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).
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))
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.).
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)
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)
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
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
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.
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
- Individual participant dataSharing planned: No. The data provided will be the property of the sponsor and will be used solely for its own research activities.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Irritable Bowel Syndrome, run by University Hospital, Rouen at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David DM MALLET, Director (02 32 88 82 65 ext. +33, david.mallet@chu-rouen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical prognostic factors for the disease (use of recreational substances) (time frame: Visit V0 (inclusion)). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2026.