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 @ 3:28 AM
Ignite Modification Date:
2025-12-25 @ 3:28 AM
NCT ID:
NCT03609905
Eligibility Criteria:
Inclusion Criteria:
* Male or female, 18-65 years old
* Diagnosis of ulcerative colitis diagnosed at least 6 months earlier
* Moderate or severe activity defined by a Mayo score
* No serious infection, chronic diseases, diabetes and tuberculosis
* Unefficient by using 5-ASA, glucocorticoid or azathioprine
* Written informed consents were obtained from all subjects
* Capable of good communication with researchers and follow the entire test requirements
* Negative pregnancy test for women of childbearing potential (from menarche to menopause)
Exclusion Criteria:
* Pregnant or breastfeeding women or cognitively impaired adults
* History of malignant disease
* Infectious colitis
* Patients with known allergies to culture medium
* Patients having participated in clinical trials with any investigational drug within 1 month prior to enrolment in this study
* Patients with suspicion of Crohn's enterocolitis, indeterminate colitis, ischaemic colitis, radiation colitis, diverticular disease associated colitis, or microscopic colitis
* Patients with previous colectomy
* Positive to one or more of the infectious disease panel
* Treatment with surgery or biological treatment (infliximab or adamizumab) or Cyclosporine or tacrolimus or mycophenolate in the 8 weeks prior to inclusion in the study
* Presence of severe concomitant diseases
* Patients with clostridium difficult or cytomegalovirus infection
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03609905
Study Brief:
Protocol Section:
NCT03609905