Status:
COMPLETED
Plant Exosomes +/- Curcumin to Abrogate Symptoms of Inflammatory Bowel Disease
Lead Sponsor:
University of Louisville
Conditions:
Irritable Bowel Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 dise...
Detailed 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 th...
Eligibility Criteria
Inclusion
- Patients must have a confirmed diagnosis of IBD (either CD or UC) with moderate disease activity.)
- Ability to independently care for oneself
Exclusion
- Pregnancy
- Known HIV
- Patients receiving immunosuppressive drugs, other than for their bowel disease
- Patients must be on stable doses of their medications for the 2 weeks prior to study entry and for the duration of the treatment period, or inform the investigator of any changes in medication
- Active malignancy in the last 5 years
- Patients receiving any other investigational agent(s)
- Ginger allergy
Key Trial Info
Start Date :
March 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 2 2022
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT04879810
Start Date
March 1 2018
End Date
August 2 2022
Last Update
November 3 2022
Active Locations (1)
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1
University of Louisville
Louisville, Kentucky, United States, 40292