Pilot Study of Green Tea Extract (Polyphenon E®)in Ulcerative Colitis
| Status: | Completed |
|---|---|
| Conditions: | Colitis, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - 85 |
| Updated: | 12/16/2017 |
| Start Date: | March 2008 |
| End Date: | April 2012 |
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
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.
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.
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
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