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 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 12:14 AM
NCT ID:
NCT06495658
Eligibility Criteria:
Inclusion Criteria:
* Ages 18 to 85 years old
* History of biopsy-proven ulcerative colitis (UC)
* Active symptoms (SCCAI \>2)
* Concomitant use of 5-aminosalicylates, immunomodulators, and corticosteroids will be permitted, although initiation or dose adjustment must not have occurred within 30 days prior to enrollment.
* Concomitant use of biologic therapy will be permitted, although initiation or dose adjustment must not have occurred within 60 days prior to enrollment.
* Prior probiotics or other dietary supplements use is permitted but will be asked to be discontinued during the course of the trial
Exclusion Criteria:
* Prior colectomy
* Hospitalization
* Urgent need for abdominal surgery
* Unstable major medical condition
* Active malignancy under treatment
* Active alcohol or non-cannabinoid substance abuse
* Pregnancy or lactation
* Concerns for non-compliance
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT06495658
Study Brief:
Protocol Section:
NCT06495658