Mild to Moderately Active Ulcerative Colitis
Conditions
Keywords
Ulcerative colitis, EGCG, Green tea polyphenols, Inflammatory bowel disease, Colitis, IBD, Green tea
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.
Interventions
DRUGPolyphenon E®
Oral capsules
DRUGPlacebo Oral Tablet
Oral tablet: placebo
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Louisville
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With a Reduction in the Disease Activity Index of >3, or Clinical Remission. | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Polyphenon E Treatment Polyphenon E®: Oral capsules | 15 |
| Placebo Oral Placebo
Placebo Oral Tablet: Oral tablet: placebo | 5 |
| Total | 20 |
Baseline characteristics
| Characteristic | Total | Polyphenon E Treatment | Placebo |
|---|---|---|---|
| Age, Continuous | 40 years STANDARD_DEVIATION 15 | 44.9 years STANDARD_DEVIATION 15 | 30.7 years STANDARD_DEVIATION 14.4 |
| Region of Enrollment United States | 20 participants | 15 participants | 5 participants |
| Sex: Female, Male Female | 8 Participants | 8 Participants | 0 Participants |
| Sex: Female, Male Male | 12 Participants | 7 Participants | 5 Participants |
| Ulcerative colitis (UC) disease activity index | 7.0 units on a scale STANDARD_DEVIATION 1.7 | 6.5 units on a scale STANDARD_DEVIATION 1.7 | 7.3 units on a scale STANDARD_DEVIATION 1.7 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 5 |
| other Total, other adverse events | 0 / 15 | 0 / 5 |
| serious Total, serious adverse events | 1 / 15 | 0 / 5 |
Outcome results
Primary
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.
Time frame: day 56
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Polyphenon E Treatment | Number of Subjects With a Reduction in the Disease Activity Index of >3, or Clinical Remission. | 10 Participants |
| Placebo | Number of Subjects With a Reduction in the Disease Activity Index of >3, or Clinical Remission. | 0 Participants |
p-value: 0.03Fisher Exact