TUDCA as a Therapy for Ulcerative Colitis (UC)

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 65 Years
Gender All
More 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04114292
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Washington University School of Medicine
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

OtherOther
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Ulcerative Colitis
Additional Details

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.

Arms & Interventions

Arms

Experimental: TUDCA

1.75-2 grams daily in divided dosing

Interventions

Drug: - Tauroursoursodeoxycholic acid, brand name Tudcabil

Dosed in capsules containing 250 or 500mg of TUDCA for a total dose of 1.75-2g/day

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Barnes-Jewish West County Hospital, Creve Coeur, Missouri

Status

Recruiting

Address

Barnes-Jewish West County Hospital

Creve Coeur, Missouri, 63141

Barnes-Jewish Hospital, Saint Louis, Missouri

Status

Recruiting

Address

Barnes-Jewish Hospital

Saint Louis, Missouri, 63110

Washington University School of Medicine, Saint Louis, Missouri

Status

Recruiting

Address

Washington University School of Medicine

Saint Louis, Missouri, 63110

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