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

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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

Study Description
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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 Design
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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
Actual Primary Completion Date : October 2011
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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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.



Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
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
Contacts and Locations
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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
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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
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Principal Investigator: Gerald W Dryden, MD, MSPH University of Louisville
More Information
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Publications of Results:

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Responsible Party: Gerald W. Dryden, Jr., Principal investigator, University of Louisville
ClinicalTrials.gov Identifier: NCT00718094    
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:
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Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
 Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases