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:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2025-12-25 @ 2:13 AM
NCT ID:
NCT04259060
Eligibility Criteria:
Inclusion Criteria:
1. Age 18-75
2. Ability to give consent
3. Patients with a confirmed diagnosis of UC for \> 3 months
4. History of \> 15 cm of colonic involvement as confirmed by colonoscopy
5. Disease activity based on calprotectin \> 200
6. Allowed medications: mesalamine and sulfasalazine
7. Partial Mayo score of \> 4 for phase one or a total Mayo score \> 5 in phase 2
8. Patients with primary sclerosing cholangitis are eligible to enroll
Exclusion Criteria:
1. History of uncontrolled hypertension with a systolic BP \> 140 and a systolic BP \> 90
2. Chronic kidney disease as defined by a GFR \<60mL/min
3. Impaired hepatic function (transaminases elevated \> 2.5 x ULN) unless due to PSC
4. Evidence of C. difficile - negative test result within 1 month is acceptable to confirm
5. Infectious Colitis or drug induced colitis
6. Crohn's Disease or Indeterminate colitis
7. Decompensated liver disease
8. Patients who are pregnant or breastfeeding
9. Prohibited medications: Vitamin C, prednisone, immune modulators (including but not limited to azathioprine, 6-mercaptopurine, mycophenolate mofetil, tacrolimus, cyclosporine, thalidomide, interleukin-10 and interleukin-11) and anti-TNF agents within the past six weeks
10. Use of rectal therapies
11. Patients who have a confirmed malignancy or cancer within 5 years
12. Participation in a therapeutic clinical trial in the preceding 30 days or simultaneously during this trial
13. Congenital or acquired immunodeficiencies
14. Other comorbidities including: Diabetes mellitus, systemic lupus
15. Patients with a history of kidney stones
16. Patients with a history or risk of cardiovascular conditions, including arrhythmia, long QT syndrome, congestive heart failure, stroke, or coronary artery disease
17. High likelihood of colectomy in the next 2 months
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04259060
Study Brief:
Protocol Section:
NCT04259060