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Completed

NCT Number: NCT02267694

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

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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Key information

Conditions

Ulcerative Colitis Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Connecticut Health Center

Farmington, Connecticut, 06030-1845, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Freeze-Dried Black Raspberry Powder

Drug

Primary outcomes

  1. Remission rate

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

UConn Health

Other

Collaborators

  • Medical College of Wisconsin

Registry information

Official study title

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

Acronym: BRB

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Oct 17, 2014
Registry last updated
Apr 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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