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 @ 11:25 PM
Ignite Modification Date:
2025-12-24 @ 11:25 PM
NCT ID:
NCT01144156
Eligibility Criteria:
Inclusion Criteria:
1. Isolated small bowel Crohn's disease.
2. Age ≥18.
3. Active disease (CDAI≥220).
Exclusion Criteria:
1. Known fixed stricture in the small intestine.
2. Former small bowel obstruction or obstructive symptoms.
3. Patients expected to undergo small bowel surgery in the near future or had intestinal surgery in the previous 6 months.
4. Colonic disease (except ileocecal valve area).
5. Anti-TNF treatment in the last 3 months.
6. Sensitivity or lack of response to previous adalimumab treatment.
7. Current gastrointestinal infection.
8. History of malignant disease (except BCC of skin).
9. Congestive heart failure, severe renal or hepatic dysfunction.
10. Patients suffering from tuberculosis, hepatitis B or C.
11. Pregnancy or unwillingness to use contraception during study period.
12. Dysphagia or swallowing disorders
13. Gastroparesis or severe gastrointestinal motility dysfunction.
14. Patients with cardiac pacemaker or implanted cardioverter devices.
15. Unable to sign informed consent.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01144156
Study Brief:
Protocol Section:
NCT01144156