Mild to Moderately Active Ulcerative Colitis Clinical Trial
Official title:
A Phase IIa Pilot Study to Determine the Safety of an Oral Dose of Green Tea Extract (Polyphenon E®) and Provide Preliminary Evidence to Support Its Efficacy in Ulcerative Colitis
| Verified date | November 2017 |
| Source | University of Louisville |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Green tea consists of several components, with most research focusing on the polyphenol fraction. The polyphenol fraction(-)-epigallocatechin-3-gallate (EGCG)has been studied extensively as an anti-inflammatory agent as well as a preventative agent for cancer. It has been shown to effectively reduce the inflammation associated with animal models of inflammatory bowel disease. This clinical trial will determine the ability of EGCG, in the form of Polyphenon E®, to treat patients with mild to moderately severe ulcerative colitis.
| Status | Completed |
| Enrollment | 20 |
| Est. completion date | April 2012 |
| Est. primary completion date | October 2011 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 85 Years |
| Eligibility |
Inclusion Criteria: - Adult male or female with mildly to moderately active ulcerative colitis Exclusion Criteria: - Off prohibited medications for proscribed period of time - Evidence of infectious colitis - Labs outside of range - Pregnancy or lactation |
| Country | Name | City | State |
|---|---|---|---|
| United States | University of Louisville Clinical Research Center | Louisville | Kentucky |
| Lead Sponsor | Collaborator |
|---|---|
| University of Louisville | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
United States,
Dryden GW, Lam A, Beatty K, Qazzaz HH, McClain CJ. A pilot study to evaluate the safety and efficacy of an oral dose of (-)-epigallocatechin-3-gallate-rich polyphenon E in patients with mild to moderate ulcerative colitis. Inflamm Bowel Dis. 2013 Aug;19(9 — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of Subjects With a Reduction in the Disease Activity Index of >3, or Clinical Remission. | This Index is a measure of ulcerative colitis severity. The index assesses four variables, which include stool frequency, severity of bleeding, colonic mucosal appearance, and the physician's overall assessment of disease activity. Each variable is scored from 0-3 so that the total index score ranges from 0-12; 0-2: remission; 3-6: mild; 7-10: moderate; >10: severe UC. |
day 56 |