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 @ 3:27 PM
Ignite Modification Date:
2025-12-24 @ 3:27 PM
NCT ID:
NCT04114292
Eligibility Criteria:
Inclusion Criteria:
* Ages Eligible for Study: 18 Years to 65 Years;
* Confirmed ulcerative colitis disease through radiographic, endoscopic and/or histologic criteria;
* Confirmed with active ulcerative colitis (defined as a complete Mayo score ≥ 5 with endoscopic subscore of ≥ 1) See Appendix for Mayo Score using recent adaptation to include any friability on endoscopy to be scored as "2".
* On a stable dose of medications for inflammatory bowel disease (IBD) (i.e. no change in medication within 4 weeks of study enrollment) and not planning to initiate new medication other than TUDCA.
Exclusion Criteria:
* Those that received other chemical chaperone therapies in the 3 months prior to screening;
* Individuals accompanied by gallstones, other intestinal disorders or cancers, or any possible cholestatic pathologies that could alter the enterohepatic circulation of the bile acids, including previous cholecystectomy or short bowel syndrome;
* Subjects with alcohol or drug abuse within the recent year;
* Serious heart, lung, kidney, digestive, nervous, mental, or autoimmune diseases
* Those with plans for abdominal surgery;
* Those unable or unwilling to provide informed consent or failure to comply with the test requirements;
* Pregnant, lactating women;
* Those receiving or planning to receive medicines that inhibit the absorption of the bile acids in the intestine;
* All female subjects must have birth control and not plan to become pregnant during the study. As TUDCA may interfere in the absorption of oral contraceptives, the acceptable methods of birth control should include abstinence or 2 of the following intrauterine device (IUD-with or without local hormone release), diaphragm, spermicides, cervical cap, contraceptive sponge, and /or condoms.
* Subjects with baseline liver transamines (AST or ALT) \> 1.5 X the upper limit of normal.
* Patients with complete biliary obstruction and known hypersensitivity or intolerance to TUDCA or any of the components of Tudcabil (or to other bile acids).
* Patients with moderate-to-severe hepatic impairment.
* Evidence of worsening liver function based on the 2 initial laboratory values used to establish the baseline.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04114292
Study Brief:
Protocol Section:
NCT04114292