Study of Freeze-dried Black Raspberry in Maintenance of Ulcerative Colitis
- Registration Number
- NCT02267694
- Lead Sponsor
- UConn Health
- Brief Summary
This research study is about adding Black Raspberry powder to the treatment regimen of patients with ulcerative colitis who are currently in remission and doing well.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 7
Inclusion Criteria
Adult patients (>18 years of age) with known diagnosis of ulcerative colitis who are currently in remission on a stable dose of 5-ASA products and/or steroids (equivalent to prednisone 20 mg or less). English speaking/reading male or female patients from all ethnicities will be considered for the study.
Exclusion Criteria
- Treatment with Immunomodulators and/or biologic agents, active disease flare, patients younger than 18 years old, patients who are pregnant or trying to get pregnant, breast feeding and those with reported history of allergy or hypersensitivity to berry products.
Patients who are using NSAIDS will also be excluded from the study but low dose ASA (81-162 mg) is permitted if needed.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Black raspberry powder Freeze-dried black raspberry powder Black raspberry powder 25 grams once daily for 4 weeks. If tolerated, will increase to 25 grams twice a day for another 20 weeks. Total length of active treatment 24 weeks.
- Primary Outcome Measures
Name Time Method Remission rate 6 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Connecticut Health Center
🇺🇸Farmington, Connecticut, United States