TUDCA as a Therapy for Ulcerative Colitis (UC)

Inclusion Criteria:

• Ages Eligible for Study: 18 Years to 65 Years;
• Confirmed ulcerative colitis disease through radiographic, endoscopic and/orhistologic criteria;
• Confirmed with active ulcerative colitis (defined as a complete Mayo score ≥ 5 withendoscopic subscore of ≥ 1) See Appendix for Mayo Score using recent adaptation toinclude any friability on endoscopy to be scored as "2".
• On a stable dose of medications for inflammatory bowel disease (IBD) (i.e. no changein medication within 4 weeks of study enrollment) and not planning to initiate newmedication other than TUDCA.

Exclusion Criteria:

• Those that received other chemical chaperone therapies in the 3 months prior toscreening;
• Individuals accompanied by gallstones, other intestinal disorders or cancers, or anypossible cholestatic pathologies that could alter the enterohepatic circulation of thebile 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 thetest requirements;
• Pregnant, lactating women;
• Those receiving or planning to receive medicines that inhibit the absorption of thebile acids in the intestine;
• All female subjects must have birth control and not plan to become pregnant during thestudy. As TUDCA may interfere in the absorption of oral contraceptives, the acceptablemethods of birth control should include abstinence or 2 of the following intrauterinedevice (IUD-with or without local hormone release), diaphragm, spermicides, cervicalcap, contraceptive sponge, and /or condoms.
• Subjects with baseline liver transamines (AST or ALT) > 1.5 X the upper limit ofnormal.
• Patients with complete biliary obstruction and known hypersensitivity or intoleranceto 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 toestablish the baseline.