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Trial record 1 of 28 for:    TUDCA
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TUDCA as a Therapy for Ulcerative Colitis (UC) (TUDCA)

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ClinicalTrials.gov Identifier: NCT04114292
Recruitment Status : Recruiting
First Posted : October 3, 2019
Last Update Posted : October 3, 2019
Sponsor:
Collaborator:
Crohn's and Colitis Foundation
Information provided by (Responsible Party):
Washington University School of Medicine

Tracking Information
First Submitted Date  ICMJE September 25, 2019
First Posted Date  ICMJE October 3, 2019
Last Update Posted Date October 3, 2019
Actual Study Start Date  ICMJE January 17, 2019
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 1, 2019)
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 ]
Change in ER stress markers as measured by expression of X box binding protein-1 (XBP1), Binding immunoglobulin protein (BIP) and Eukaryotic Translation Initiation Factor 2A (eIF2a) in colon biopsy tissues before and after 6 weeks of TUDCA treatment.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 1, 2019)
  • 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) ]
    Monitor and define TUDCA safety/tolerability in this population through frequent monitoring and symptom assessment as detailed in the study procedures. Adverse events will be categorized according to CTCAE v5.0 criteria and grading.
  • Change ulcerative colitis disease activity based on Total Mayo Score [ Time Frame: Baseline and post 6 weeks of TUDCA treatment ]
    The Mayo Ulcerative colitis score is an aggregate of individual parameters evaluating rectal bleeding, stool frequency, endoscopic severity and physicians global assessment. Each of these subscores has a range from 0-3 where 3 is worse. a total score can range from 0 to 12 with 0 being in remission and 12 representing the most severe disease. As this is a secondary endpoint in a small trial, patients total scores (out of 12) will be compared from baseline to week 6 using a paired students t test. Mayo score reference is Schroeder KW, Tremaine WJ, Ilstrup DM. Coated oral 5-aminosalicylic acid therapy for mildly to moderately active ulcerative colitis. A randomized study. N Engl J Med 1987;317:1625-9.
  • Change in inflammation on histology by Goebes index [ Time Frame: Baseline and post 6 weeks of TUDCA treatment ]
    The Geboes histology index is a reproducible grading scale for histological assessment of inflammation in ulcerative colitis. This is a six grade classification system for inflammation which can also be fine tuned within each grade. The grades are: 0, structural change only; 1, chronic inflammation; 2, lamina propria neutrophils; 3, neutrophils in epithelium; 4, crypt destruction; and 5, erosions or ulcers. As this is a secondary endpoint in a small trial, patients total scores (out of 20) will be compared from baseline to week 6 using a paired students t test. Higher scores represent more severe disease. The reference for the Geboes index is "Geboes K, Riddell R, Ost A, et al. A reproducible grading scale for histological assessment of inflammation in ulcerative colitis. Gut 2000;47:404-9."
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE TUDCA as a Therapy for Ulcerative Colitis (UC)
Official Title  ICMJE A Phase I Open Label Study of the Efficacy and Safety of Tudca in Ulcerative Colitis
Brief Summary This is a Phase I open label study examining the efficacy and safety of TUDCA (tauroursodeoxycholic acid) in ulcerative colitis treatment.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Determine the effect of TUDCA treatment on colon inflammation including ER stress in colon biopsy tissues from subjects with symptomatic ulcerative colitis. Secondary: Measure the safety, tolerance and efficacy of TUDCA treatment in symptomatic ulcerative colitis.
Masking: None (Open Label)
Masking Description:
Open-label study. All patients will receive TUDCA.
Primary Purpose: Health Services Research
Condition  ICMJE Ulcerative Colitis
Intervention  ICMJE Drug: Tauroursoursodeoxycholic acid, brand name Tudcabil
Dosed in capsules containing 250 or 500mg of TUDCA for a total dose of 1.75-2g/day
Other Name: Tudcabil
Study Arms  ICMJE Experimental: TUDCA
1.75-2 grams daily in divided dosing
Intervention: Drug: Tauroursoursodeoxycholic acid, brand name Tudcabil
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 1, 2019)
12
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2020
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Matthew A Ciorba, MD 3142730301 mciorba@wustl.edu
Contact: Lulu Huang 3142730301 luluhuang@wustl.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04114292
Other Study ID Numbers  ICMJE 201812101
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Washington University School of Medicine
Study Sponsor  ICMJE Washington University School of Medicine
Collaborators  ICMJE Crohn's and Colitis Foundation
Investigators  ICMJE Not Provided
PRS Account Washington University School of Medicine
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP