Could a bile acid pill ease ulcerative colitis?
NCT ID NCT04114292
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase study tested whether TUDCA, a bile acid supplement, is safe and can reduce stress in gut cells of people with active ulcerative colitis. Fourteen adults took TUDCA for 6 weeks while researchers measured changes in cell stress markers from colon biopsies. The goal was to see if TUDCA could help control the disease, not cure it.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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14 people
The number who actually took part.
- Started
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Jan 2019
- Finished
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Jun 2022
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Barnes-Jewish Hospital
St Louis, Missouri, 63110, United States
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Barnes-Jewish West County Hospital
Creve Coeur, Missouri, 63141, United States
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Washington University School of Medicine
St Louis, Missouri, 63110, United States
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