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 @ 12:18 PM
Ignite Modification Date:
2025-12-24 @ 12:18 PM
NCT ID:
NCT02199561
Eligibility Criteria:
Inclusion Criteria:
1. Age \> 18 and \< 65 years at the time of screening
2. Diagnosis of ileo-colonic or colonic CD for \> 3 months but \< 5 years prior to screening as determined by the investigators
3. Those with mild to moderate CD
4. Those who have failed maintenance therapy with stable doses of 5-ASA, azathioprine, 6 mercaptopurine (6-MP) or methotrexate for \> 3 months
5. Where applicable, those who are taking the following medications must be at a stable dose defined as:
i) 5-ASA must be at a stable dose for 2 weeks ii) Prednisone up to 20 mg/d must be at a stable dose for 2 weeks iii) Budesonide up to 6 mg/d must be at a stable dose for 2 weeks iv) Azathioprine, 6-MP, and methotrexate must be at a stable dose for \> 8 weeks
6. ability to provide informed consent
7. evidence of active colonic inflammation
Exclusion Criteria:
1. Those with prior ileo-cecal resection
2. Those who are pregnancy or plan to be pregnant during the trial
3. Those who are breastfeeding or plan to breast feed during the trial
4. Those who are on or have previously failed a biological agent
5. Those who have active perianal disease as determined by investigators
6. Those with an active infection requiring antibiotic therapy
7. Those with positive stool cultures for known pathogens such as E coli, Salmonella, Shigella, Yersinia, Campylobacter, and Clostridium difficile toxin within 2 weeks of enrollment
8. Those with positive CMV on colonic tissue biopsy within 2 weeks of screening
9. Those with allergy to ciprofloxacin and metronidazole
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02199561
Study Brief:
Protocol Section:
NCT02199561