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:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2025-12-25 @ 2:47 AM
NCT ID:
NCT04997733
Eligibility Criteria:
Inclusion Criteria for patients :
* Age ≥ 18 years and \< 75 years
* Crohn's disease (according to the Lennard-Jones criteria) for at least 6 months
* Patient in steroid-free clinical remission for at least 6 months under anti-TNF agent (no clinical evidence of flare nor change in Crohn's disease specific treatment (anti-TNF, immunosuppressive, …) within 6 months before inclusion) and CDAI \<150 the week before inclusion) and willing to withdraw anti-TNF treatment
* Female of child-bearing age with an active contraception and this during at least the period of treatment (week 52)
* Patient with health insurance
* Informed Written consent
Inclusion Criteria for healthy volunteer donor :
* Age ≥ 18 years and \< 50 years
* 17 kg/m² \< body mass index \< 30 kg/m²
* Regular bowel movement defined as at least 1 stool every other day and maximum 2 stools per day
* Subject with health insurance (AME excepted)
* Informed written consent
Exclusion Criteria for patients :
* Crohn's Disease complication requiring surgical treatment
* Contraindication to colonoscopy or anesthesia
* Pregnancy or breastfeeding during the study (Cf. Addendum 4)
* Diagnosis of Crohn's disease restricted to the upper gastrointestinal tract (oesophagus, stomach, duodenum, jejunum)
* Patient with active perineal disease (defined as evidence of perineal abscess or active draining fistula or presence of seton or presence of perineal ulceration)
* History of more than one small bowel resection or small intestine resection \> 1 meter
* Current stoma (Ileostomy or a colostomy) or stoma in the last 6 months or any other intra-abdominal surgery within 3 months prior to inclusion
* Participation in any other interventional study
* Patient under legal protection
Exclusion Criteria for healthy volunteer donor :
\- For details, please see protocol
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
74 Years
Study:
NCT04997733
Study Brief:
Protocol Section:
NCT04997733