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 @ 7:10 PM
Ignite Modification Date:
2025-12-24 @ 7:10 PM
NCT ID:
NCT01569503
Eligibility Criteria:
Inclusion Criteria:
* Patients with CD involving the ileo-colon, diagnosed for at least 3 months prior to screening in flare (220\<CDAI\<450) of their disease despite a treatment reference (corticosteroids and/or immunosuppressives) with a stable dose will be included
* CRP\>5mg/l and/or fecal calprotectin \<100µg/l
* CDEIS \> 7 (Crohn's disease endoscopic index of severity)
* Consenting patient
Exclusion Criteria:
* Known cardiac pathology
* VNS contraindication
* Anoperineal CD only or associated with ileocolic lesion
* Diagnosis of indeterminate colitis, positive stool culture for enteric pathogens
* CD Surgery within 3 months before screening
* Short small intestine (\<1m)
* Koenig syndrome
* Intra-abdominal abscess
* Fistula with clinical or radiological abscess evidence
* Anoperineal CD with or without rectal involvement
* Ileostomy, colostomy, enteral or parenteral feeding
* Clinical condition medically or surgically unstable that, at the discretion of the investigator would not be compatible with the patient's participation in the study
* Any recent neoplasia, in the year prior to screening
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01569503
Study Brief:
Protocol Section:
NCT01569503