Study of Freeze-dried Black Raspberry in Maintenance of Ulcerative Colitis (BRB)

UConn Health

Status and phase: Completed; Phase 1

Conditions: Ulcerative Colitis

Treatments: Drug: Freeze-dried black raspberry powder

Study type: Interventional

Funder types: Other

Identifiers

NCT02267694

BRB113728

Details and patient eligibility

About

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.

Enrollment: 7 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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7 participants in 1 patient group

Black raspberry powder

Other group

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.

Treatment:

Drug: Freeze-dried black raspberry powder