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Bile Acid
TUDCA for Colitis (TUDCA Trial)
Phase 1
Waitlist Available
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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)
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a dietary supplement called TUDCA to see if it can help people with active ulcerative colitis by reducing inflammation in their intestines. The study will check both the safety and effectiveness of TUDCA over a period of several weeks.
Eligible Conditions
- Colitis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 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)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Determine the effect of TUDCA treatment on ER stress in colon biopsy tissues from subjects with symptomatic ulcerative colitis
Secondary study objectives
Change in inflammation on histology by Goebes index
Change ulcerative colitis disease activity based on Total Mayo Score
Monitoring of UC patients for TUDCA safety and tolerability: Adverse events
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: TUDCAExperimental Treatment1 Intervention
1.75-2 grams daily in divided dosing
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Washington University School of MedicineLead Sponsor
1,991 Previous Clinical Trials
2,295,871 Total Patients Enrolled
Crohn's and Colitis FoundationOTHER
43 Previous Clinical Trials
27,489 Total Patients Enrolled
15 Trials studying Colitis
2,021 Patients Enrolled for Colitis
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