Back to resultsStudy of Freeze-dried Black Raspberry in Maintenance of Ulcerative Colitis (BRB)
Primary Purpose
Ulcerative Colitis
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Freeze-dried black raspberry powder
Sponsored by
About this trial
This is an interventional treatment trial for Ulcerative Colitis
Eligibility Criteria
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.
Sites / Locations
- University of Connecticut Health Center
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Black raspberry powder
Arm Description
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.
Outcomes
Primary Outcome Measures
Remission rate
Secondary Outcome Measures
Full Information
NCT ID
NCT02267694
First Posted
October 14, 2014
Last Updated
April 10, 2017
Sponsor
UConn Health
Collaborators
Medical College of Wisconsin
1. Study Identification
Unique Protocol Identification Number
NCT02267694
Brief Title
Study of Freeze-dried Black Raspberry in Maintenance of Ulcerative Colitis
Acronym
BRB
Official Title
A Trial of Freeze-dried Black Raspberry in Maintenance of Remission of Ulcerative Colitis
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
October 5, 2015 (Actual)
Study Completion Date
November 13, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UConn Health
Collaborators
Medical College of Wisconsin
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Black raspberry powder
Arm Type
Other
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Freeze-dried black raspberry powder
Primary Outcome Measure Information:
Title
Remission rate
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Haleh Vaziri, MD
Organizational Affiliation
UConn Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Connecticut Health Center
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030-1845
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study of Freeze-dried Black Raspberry in Maintenance of Ulcerative Colitis
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