Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04879810 |
| Other study ID # |
15.0872 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 1, 2018 |
| Est. completion date |
August 2, 2022 |
Study information
| Verified date |
November 2022 |
| Source |
University of Louisville |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The trial will test the hypothesis that edible structures within plant cells (ginger) will
have clinically important anti-inflammatory effects on the gut lining of patients with
inflammable bowel disease.
To evaluate the safety and tolerability of exosomes with and without curcumin in patients
with Inflammatory Bowel Disease (IBD); To estimate the effect of ginger exosomes or curcumin
alone or combined with curcumin on the symptoms and disease score in patients with refractory
IBD describe toxicities associated with ginger exosomes; to evaluate the effect of ginger
exosomes on biomarkers of inflammation.
Description:
Up to 90 patients with Chronic IBD will be enrolled, with the goal of having three arms of 30
subjects in each group who are eligible for evaluation.
This exploratory trial is designed to estimate the effect of ginger exosomes or curcumin on
IBD symptoms compared to ginger exosomes plus curcumin. In this prospective and randomized
study the main focus is to compare exosomes alone, curcumin, and exosomes plus curcumin.
Three primary stratification factors race (white and black), gender and type of IBD (CD and
UC) will be used. plan Zelen's (1974) method will be used to avoid imbalance allocation
within each stratum. A block size of 4 will be used. We plan to enroll all eligible patients
visiting the clinic, as well as eligible patients referred from other gastroenterologists.
All eligible visiting our clinic will be enrolled. By enrolling consecutive patients, we
reduce selection bias. A patient will be enrolled only once.
The most important aim of this study is to compare the IBD symptoms in exosomes alone and
exosomes plus curcumin groups of patients. The symptomatology will be measured in each group
and compared to the self-reported score. We will use the incidence rate of bloody stool to
justify the sample size. With the combination treatment (ginger exosomes plus curcumin as
compared to curcumin alone) we hope to reduce symptoms by at least 30%. Using a two sample
one-sided t test for comparing mean differences in Inflammatory Bowel Disease Questionnaire,
with 30 subjects in each group and using alpha=5%, we will have 80% power to detect effect
size of 0.65 Standard Deviation, which is a large effect size (Cohen, 1988).. When the
reduction in sample size due to missing data or other reasons, we will have reduced power to
detect the difference in two groups.
