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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2015-11-13

Brief Summary

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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.

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Detailed Description

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Conditions

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Ulcerative Colitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

Freeze-dried black raspberry powder

Intervention Type DRUG

Interventions

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Freeze-dried black raspberry powder

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No