TUDCA as a Therapy for Ulcerative Colitis (UC)

• Register: ClinicalTrials.gov
• Last refreshed on: 4 January 2022
• Main ID: NCT04114292
• Date of registration: 25/09/2019
• Prospective Registration: No
• Primary sponsor: Washington University School of Medicine
• Public title: TUDCA as a Therapy for Ulcerative Colitis (UC) TUDCA
• Scientific title: A Phase I Open Label Study of the Efficacy and Safety of Tudca in Ulcerative Colitis
• Date of first enrolment: January 17, 2019
• Target sample size: 13
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT04114292
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Health Services Research. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: Matthew A Ciorba, MD

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Ulcerative Colitis

Intervention(s)

Drug: Tauroursoursodeoxycholic acid, brand name Tudcabil

Primary Outcome(s)

Determine the effect of TUDCA treatment on ER stress in colon biopsy tissues from subjects with symptomatic ulcerative colitis [Time Frame: Baseline and post 6 weeks of TUDCA treatment]

Secondary Outcome(s)

Monitoring of UC patients for TUDCA safety and tolerability: Adverse events [Time Frame: Every 2 weeks after starting TUDCA until 2 weeks after completing 6 weeks of TUDCA treatment. (i.e. study points weeks 2, 4, 6 and 8)]

Change ulcerative colitis disease activity based on Total Mayo Score [Time Frame: Baseline and post 6 weeks of TUDCA treatment]

Change in inflammation on histology by Goebes index [Time Frame: Baseline and post 6 weeks of TUDCA treatment]

Secondary ID(s)

201812101

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Crohn's and Colitis Foundation