Regional cohort for patients with irritable bowel syndrome
Development of a Regional Irritable Bowel Syndrome Cohort
This study is trying to learn more about irritable bowel syndrome by following around 600 patients for 2.5 years to see how the condition affects them and how it can be treated better.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 600 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Rouen Academic / other |
| Locations | 4 sites (Amiens and 3 other locations) |
| Trial ID | NCT06900491 on ClinicalTrials.gov |
What this trial studies
This project aims to establish a multicentre, longitudinal cohort of individuals suffering from irritable bowel syndrome (IBS) to study the natural history and prognosis of the disease. The study will involve comprehensive phenotyping of patients through questionnaires, physiological explorations, and stool sample analyses to assess microbiota and metabolites. Over a period of 2.5 years, the study plans to include approximately 600 patients, allowing for the identification of subgroups with similar clinical or biological characteristics. This approach will facilitate a better understanding of IBS and its treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old who have been diagnosed with irritable bowel syndrome and have normal laboratory work-ups.
Not a fit: Patients with organic digestive pathologies or major digestive surgeries, as well as those who do not speak or understand French, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of irritable bowel syndrome, potentially enhancing patient outcomes.
How similar studies have performed: Other studies have successfully utilized similar cohort approaches to understand IBS, indicating that this methodology is both tested and promising.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Amiens and 3 other locations
- University Hospitol of Amiens — Amiens, France (Not_yet_recruiting)
- CHU de CAEN — Caen, France (Not_yet_recruiting)
- University Hospital of Lille — Lille, France (Not_yet_recruiting)
- University Rouen Hospital — Rouen, France (Recruiting)
Study contacts
- Study coordinator: David DM MALLET, Director
- Email: david.mallet@chu-rouen.fr
- Phone: 02 32 88 82 65
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.