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

November 14, 2017 updated by: Gerald W. Dryden, Jr., University of Louisville

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • University of Louisville Clinical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Polyphenon E treatment
Polyphenon E® therapy was given for 56 days.
Drug: Polyphenon E®
Oral capsules
Placebo Comparator: Placebo
Oral Placebo
Drug: Placebo Oral Tablet
Oral tablet: placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Subjects With a Reduction in the Disease Activity Index of >3, or Clinical Remission.
Time Frame: day 56

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Louisville

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

  • Principal Investigator: Gerald W Dryden, MD, MSPH, University of Louisville

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

July 16, 2008

First Submitted That Met QC Criteria

July 16, 2008

First Posted (Estimate)

July 18, 2008

Study Record Updates

Last Update Posted (Actual)

December 14, 2017

Last Update Submitted That Met QC Criteria

November 14, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 390.05
  • 5K23DK073750 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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