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 @ 5:03 PM
Ignite Modification Date:
2025-12-24 @ 5:03 PM
NCT ID:
NCT04398550
Eligibility Criteria:
Inclusion Criteria:
* History of active ulcerative colitis for at least 3 months before screening
* Ulcerative colitis confirmed by colonoscopy or flexible sigmoidoscopy within 2 years of screening
* Mild to moderate ulcerative colitis at the time of screening (2 \< Mayo score \< 12)
* 1 ≤ Endoscopy subscore ≤ 2, or fecal calprotectin \> 150 mcg/g within 2 weeks of screening
* Patients on 5-aminosalicylates (e.g. mesalamine, etc.) must be on a stable dose for ≥ 4 weeks prior to screening
* Patients on treatment with immunosuppressive (azathioprine/6-mercaptopurine and methotrexate) or biologic medications (infliximab, adalimumab, and golimumab) must be on stable dose for 8 weeks prior to baseline
* At the time of baseline, patients may be on no more than 20 mg of prednisone and 9 mg of budesonide MMX
Exclusion Criteria:
* Patients with Crohn's disease or indeterminate colitis
* History of colectomy
* Presence of ileal pouch or ostomy
* History of colonic dysplasia
* Evidence of active bacterial or viral gastroenteritis as indicated by positive stool studies for ova \& parasites, clostridium difficile, and stool culture
* Severe to fulminant colitis
* Recent hospitalizations (within 2 weeks of screening) for ulcerative colitis requiring IV steroids
* Recent systemic antibiotics use (within 2 weeks of screening)
* Presence of the following labs indicative of severe colitis: a. Hemoglobin \< 8.0 g/dl b. Albumin \< 3.0 g/dl
* Use of Total Parenteral Nutrition (TPN)
* Active use of anti-diarrheal medications
* Use of cyclosporine, tacrolimus, or thalidomide within 2 months prior to screening
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04398550
Study Brief:
Protocol Section:
NCT04398550