Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:48 PM
Ignite Modification Date:
2025-12-24 @ 1:48 PM
NCT ID:
NCT02874495
Eligibility Criteria:
Inclusion Criteria:
* For patients :
* Patients over 18 years and less than 60 years.
* Right-handed.
* Diagnosis of Crohn's disease established on clinical biological, endoscopic and anatomopathological criteria.
* Ideal localization and/or diarrhea of Crohn's Disease, with an absence of rectal or anoperineal ravages past or presents in order to not do distension on rectal/ and anoperineal lesions.
* Crohn's disease treatment authorize : 5-aminosalicylates since at least 4 weeks with a stable dose since at least 2 weeks ; immunosuppressive drugs since at least 12 weeks with a stable dose since at least 4 weeks ; anti-TNF since at least 3 months with a stable dose since at least 1 month ; absence of corticosteroid treatment since at least 15 days.
* Clinical remission : Crohn's Disease Activity Index (CDAI) \< 150 (Best 1976) and biological : normal CRP and faecal calprotectin \< 100 g/g.
* Patient able to understand and follow necessary commissions for the conduct of the clinical trial, and that have given his free written consent for this study.
* Registered to a French social security.
* The person won't be allow to participate simultaneously to another study and there won't be an exclusion period to participation to a clinical or therapeutic trial at the end of this study.
* For healthy volunteers
* Patients over 18 years and less than 60 years.
* Right-handed.
* Paired with patients for sex and age.
* Absence of digestive surgical or medical history except appendectomy, hysterectomy, cholecystectomy, inguinal hernia cure and/or femoral.
* Absence of digestive symptomatology searched while a standardized interrogation.
* Clinical digestive exam normal.
* The person won't be allow to participate simultaneously to another study and there won't be an exclusion period to. participation to a clinical or therapeutic trial at the end of this study.
* Registered to a French social security.
* Registered to the national file of persons participating to biomedicals searches without direct individual profit.
Exclusion Criteria:
* Subjet under 18 years and more than 60 years.
* Counter-argument for MRI : presence of intra-corporeal ferro-magnetic particles, claustrophobia.
* Existence of a severe condition on general level (cardiac, respiratory, hematological, renal, hepatic, cancerous).
* Existence of an organic digestive affection (gastritis, gallstones, duodenal ulcer, megacolon, inflammatory colitis).
* Existence or history malignant gastrointestinal condition.
* History of abdominal digestive surgery except appendectomy, hysterectomy, cure of inguinal hernia)
* Recto-anal or périneal active pathology (haemorrhoid , anal fissure …).
* Presence of arectal fecal impaction.
* Patient included in an other clinical or therapeutic trial.
* Patient treated by a drug sensitive to modify sensitivity and/or digestive motor function.
* Patient regularly receiving psychotropic drugs (anxiolytics, sedatives, antidepressants, neuroleptics).
* Patient with a pathology that could modify visceral sensitivity like diabetes or neurodegenerative diseases.
* Persons concerned by articles L1121-5 to L1121-8 of CSP.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT02874495
Study Brief:
Protocol Section:
NCT02874495