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

Overview

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.

Full Title of Study: “A Trial of Freeze-dried Black Raspberry in Maintenance of Remission of Ulcerative Colitis”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 5, 2015

Interventions

  • Drug: Freeze-dried black raspberry powder

Arms, Groups and Cohorts

  • Other: 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.

Clinical Trial Outcome Measures

Primary Measures

  • Remission rate
    • Time Frame: 6 months

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 90 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • UConn Health
  • Collaborator
    • Medical College of Wisconsin
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Haleh Vaziri, MD, Principal Investigator, UConn Health

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