TUDCA as a Therapy for Ulcerative Colitis (UC)

A Phase I Open Label Study of the Efficacy and Safety of Tudca in Ulcerative Colitis

This is a Phase I open label study examining the efficacy and safety of TUDCA (tauroursodeoxycholic acid) in ulcerative colitis treatment.

TUDCA (tauroursodeoxycholic acid) is a dietary supplement that has shown to reduce cellular stress related to inflammation. In this Phase I study, patients with active ulcerative colitis will be receive TUDCA for six weeks. Safety and tolerability will be assessed. Efficacy will be assessed using ulcerative colitis disease activity measurements as well as markers of intestinal inflammation before and after treatment. The overall goal of this project is to determine TUDCA can provide a new therapeutic option with a desirable safety profile for patients with ulcerative colitis focused on the inflamed intestinal epithelium.

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.