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

NCT00718094 | Completed Phase 2 Results DMC

• 2 other identifiers: 390.055K23DK073750
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild to Moderately Active Ulcerative Colitis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  day 56

Study Arms (2)

Polyphenon E treatment

EXPERIMENTAL

Polyphenon E® therapy was given for 56 days.

Drug: Polyphenon E®

Placebo

PLACEBO COMPARATOR

Oral Placebo

Drug: Placebo Oral Tablet

Interventions

Polyphenon E® DRUG

Oral capsules

Polyphenon E treatment

Placebo Oral Tablet DRUG

Oral tablet: placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult male or female with mildly to moderately active ulcerative colitis

You may not qualify if:

• Off prohibited medications for proscribed period of time
• Evidence of infectious colitis
• Labs outside of range
• Pregnancy or lactation

Sponsors & Collaborators

• University of Louisville: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of Louisville Clinical Research Center

Louisville, Kentucky, 40202, United States

Location

Related Publications (1)

• 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.

  PMID: 23846486 RESULT

MeSH Terms

Conditions

Colitis, Ulcerative; Inflammatory Bowel Diseases; Colitis

Interventions

polyphenon E

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases

Results Point of Contact

• Title: Gerald Dryden, MD
• Organization: University Louisville

gwdryd01@louisville.edu

502-852-0156

Study Officials

• Gerald W Dryden, MD, MSPH

  University of Louisville

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: July 16, 2008
• First Posted: July 18, 2008
• Study Start: March 1, 2008
• Primary Completion: October 1, 2011
• Study Completion: April 1, 2012
• Last Updated: December 14, 2017
• Results First Posted: December 14, 2017

Record last verified: 2017-11

Locations

US (1)