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 @ 4:04 PM
Ignite Modification Date:
2025-12-24 @ 4:04 PM
NCT ID:
NCT00038766
Eligibility Criteria:
Inclusion Criteria
* Baseline Crohn's Disease Activity Index (CDAI) 250-400, inclusive
* Crohn's disease of at least 3 months duration, with colitis, ileitis, or ileocolitis, confirmed by radiography and/or endoscopy
* Patients receiving medications for CD must be on stable doses entering the study
* Any CD medication which has been discontinued must have been discontinued at least 4 weeks prior to screening, with the exception of infliximab, which must have been discontinued at least 8 weeks prior to screening
Exclusion Criteria
* Patients with any ostomy or extensive bowel resection
* Current evidence of bowel obstruction or history within the preceding six months as confirmed by radiography, endoscopy, or surgery
* Patients with stool examination positive for enteric pathogens, pathogenic ova or parasites, or Clostridium difficile toxin
* Treatment with any other experimental therapeutics within the last 4 weeks before enrollment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00038766
Study Brief:
Protocol Section:
NCT00038766