Pilot Study of Green Tea Extract (Polyphenon E®)in Ulcerative Colitis

University of Louisville (UOFL)

Status and phase: Completed; Phase 2

Conditions: Mild to Moderately Active Ulcerative Colitis

Treatments: Drug: Placebo Oral Tablet; Drug: Polyphenon E®

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00718094

5K23DK073750 (U.S. NIH Grant/Contract)

390.05

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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20 participants in 2 patient groups, including a placebo group

Polyphenon E treatment

Experimental group

Description:

Polyphenon E® therapy was given for 56 days.

Treatment:

Drug: Polyphenon E®

Placebo

Placebo Comparator group

Description:

Oral Placebo

Treatment:

Drug: Placebo Oral Tablet