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

Primary Purpose

Mild to Moderately Active Ulcerative Colitis

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Polyphenon E®

Placebo Oral Tablet

About this trial

This is an interventional treatment trial for Mild to Moderately Active Ulcerative Colitis focused on measuring Ulcerative colitis, EGCG, Green tea polyphenols, Inflammatory bowel disease, Colitis, IBD, Green tea

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Louisville Clinical Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Polyphenon E treatment

Placebo

Arm Description

Polyphenon E® therapy was given for 56 days.

Oral Placebo

Outcomes

Primary Outcome Measures

Number of Subjects With a Reduction in the Disease Activity Index of >3, or Clinical Remission.

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT00718094

First Posted

July 16, 2008

Last Updated

November 14, 2017

Sponsor

University of Louisville

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT00718094

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

November 2017

Overall Recruitment Status

Completed

Study Start Date

March 2008 (undefined)

Primary Completion Date

October 2011 (Actual)

Study Completion Date

April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Louisville

Collaborators

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

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Mild to Moderately Active Ulcerative Colitis

Keywords

Ulcerative colitis, EGCG, Green tea polyphenols, Inflammatory bowel disease, Colitis, IBD, Green tea

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Polyphenon E treatment

Arm Type

Experimental

Arm Description

Polyphenon E® therapy was given for 56 days.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Oral Placebo

Intervention Type

Drug

Intervention Name(s)

Polyphenon E®

Intervention Description

Oral capsules

Intervention Type

Drug

Intervention Name(s)

Placebo Oral Tablet

Intervention Description

Oral tablet: placebo

Primary Outcome Measure Information:

Title

Number of Subjects With a Reduction in the Disease Activity Index of >3, or Clinical Remission.

Description

Time Frame

day 56

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gerald W Dryden, MD, MSPH

Organizational Affiliation

University of Louisville

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Louisville Clinical Research Center

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40202

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

23846486

Citation

Dryden GW, Lam A, Beatty K, Qazzaz HH, McClain CJ. A pilot study to evaluate the safety and efficacy of an oral dose of (-)-epigallocatechin-3-gallate-rich polyphenon E in patients with mild to moderate ulcerative colitis. Inflamm Bowel Dis. 2013 Aug;19(9):1904-12. doi: 10.1097/MIB.0b013e31828f5198.

Results Reference

result

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

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