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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Louisville
ClinicalTrials.gov Identifier:
NCT00718094
First received: July 16, 2008
Last updated: June 29, 2012
Last verified: June 2012
  Purpose

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 Intervention Phase
Mild to Moderately Active Ulcerative Colitis
Drug: Polyphenon E®
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by University of Louisville:

Primary Outcome Measures:
  • A reduction in the Disease Activity Index of >3, or clinical remission. [ Time Frame: Two years ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: March 2008
Study Completion Date: April 2012
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Low dose Polyphenon E®
Drug: Polyphenon E®
Oral capsules
Experimental: 2
High dose Polyphenon E®
Drug: Polyphenon E®
Oral capsules
Placebo Comparator: 3 Drug: Polyphenon E®
Oral capsules

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00718094

Locations
United States, Kentucky
University of Louisville Clinical Research Center
Louisville, Kentucky, United States, 40202
Sponsors and Collaborators
University of Louisville
Investigators
Principal Investigator: Gerald W Dryden, MD, MSPH University of Louisville
  More Information

No publications provided

Responsible Party: University of Louisville
ClinicalTrials.gov Identifier: NCT00718094     History of Changes
Other Study ID Numbers: 390.05, 5K23DK073750
Study First Received: July 16, 2008
Last Updated: June 29, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Louisville:
Ulcerative colitis
EGCG
Green tea polyphenols
Inflammatory bowel disease
Colitis
IBD
Green tea

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

ClinicalTrials.gov processed this record on October 21, 2014