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

This study is currently recruiting participants.

Verified by University of Louisville, July 2008

Sponsors and Collaborators:	University of Louisville National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by:	University of Louisville
ClinicalTrials.gov Identifier:	NCT00718094

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 II

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Ulcerative Colitis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

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 ]

Estimated Enrollment:	20
Study Start Date:	March 2008
Estimated Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Low dose Polyphenon E®	Drug: Polyphenon E® Oral capsules
2: Experimental High dose Polyphenon E®	Drug: Polyphenon E® Oral capsules
3: Placebo Comparator	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

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

Contacts

Contact: Karen Beatty, RN

502-562-4797

ksbeat01@gwise.louisville.edu

Locations

United States, Kentucky
University of Louisville Clinical Research Center	Recruiting
Louisville, Kentucky, United States, 40202
Contact: Karen Beatty, RN 502-562-4797 ksbeat01@gwise.louisville.edu
Principal Investigator: Gerald W Dryden, MD, MSPH

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

More Information

Responsible Party:	University of Louisville ( Gerald Dryden, MD, MSPH )
Study ID Numbers:	390.05, 5K23DK073750
Study First Received:	July 16, 2008
Last Updated:	July 16, 2008
ClinicalTrials.gov Identifier:	NCT00718094
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

Study placed in the following topic categories:

Digestive System Diseases
Gastrointestinal Diseases
Ulcer
Colonic Diseases
Inflammatory Bowel Diseases

Colitis, Ulcerative
Gastroenteritis
Intestinal Diseases
Colitis

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on January 13, 2009