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 @ 10:53 PM
Ignite Modification Date:
2025-12-24 @ 10:53 PM
NCT ID:
NCT00317369
Eligibility Criteria:
Inclusion Criteria:
* Patients with active Crohn's disease
* Patients who have a primary lesion in either the small intestine or the large intestine
* Patients who have been receiving an oral 5-ASA formulation at a fixed regimen and at a fixed dose
* Patients who have either never received enteral nutrition or have been receiving enteral nutrition at a fixed intake of 1200 kcal/day or less
* Either inpatient or outpatient
Exclusion Criteria:
* Patients who have an external fistula (including anal fistula) in which persistent drainage is observed (and who require treatment with antibiotics or synthetic antibacterial agents)
* Patients with short bowel syndrome (and who require intravenous nutritional support due to insufficient intestinal nutrient uptake)
* Patients with an artificial anus
* Patients who have a complication of serious infectious disease (intra-abdominal abscess, etc.)
* Patients who have a complication of malignant tumor
* Female patients who are pregnant, lactating, or possibly pregnant, or who wish to become pregnant during the study period
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Maximum Age:
65 Years
Study:
NCT00317369
Study Brief:
Protocol Section:
NCT00317369