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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00718094
Recruitment Status : Completed
First Posted : July 18, 2008
Results First Posted : December 14, 2017
Last Update Posted : December 14, 2017
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Gerald W. Dryden, Jr., University of Louisville

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Mild to Moderately Active Ulcerative Colitis Drug: Polyphenon E® Drug: Placebo Oral Tablet Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : March 2008
Primary Completion Date : October 2011
Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. 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.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00718094


Locations
United States, Kentucky
University of Louisville Clinical Research Center
Louisville, Kentucky, United States, 40202
Sponsors and Collaborators
University of Louisville
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Gerald W Dryden, MD, MSPH University of Louisville

Publications:
Responsible Party: Gerald W. Dryden, Jr., Principal investigator, University of Louisville
ClinicalTrials.gov Identifier: NCT00718094     History of Changes
Other Study ID Numbers: 390.05
5K23DK073750 ( U.S. NIH Grant/Contract )
First Posted: July 18, 2008    Key Record Dates
Results First Posted: December 14, 2017
Last Update Posted: December 14, 2017
Last Verified: November 2017

Keywords provided by Gerald W. Dryden, Jr., University of Louisville:
Ulcerative colitis
EGCG
Green tea polyphenols
Inflammatory bowel disease
Colitis
IBD
Green tea

Additional relevant MeSH terms:
Colitis
Ulcer
Colitis, Ulcerative
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases