Study of Freeze-dried Black Raspberry in Maintenance of Ulcerative Colitis

Ulcerative Colitis Clinical Trial

— BRB  

Official title:

A Trial of Freeze-dried Black Raspberry in Maintenance of Remission of Ulcerative Colitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02267694
• Other study ID #: BRB113728
• Status: Completed
• Phase: Phase 1
• First received: October 14, 2014
• Last updated: April 10, 2017
• Start date: August 2013
• Est. completion date: November 13, 2015

Study information

• Verified date: April 2017
• Source: UConn Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: November 13, 2015
• Est. primary completion date: October 5, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Drug:
• Freeze-dried black raspberry powder

Locations

Country	Name	City	State
United States	University of Connecticut Health Center	Farmington	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
UConn Health	Medical College of Wisconsin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Remission rate		6 months