NCT02267694

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Aug 2013

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

October 14, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 17, 2014

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 5, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 13, 2015

Completed
Last Updated

April 11, 2017

Status Verified

April 1, 2017

Enrollment Period

2.2 years

First QC Date

October 14, 2014

Last Update Submit

April 10, 2017

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

  • Remission rate

    6 months

Study Arms (1)

Black raspberry powder

OTHER

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.

Drug: Freeze-dried black raspberry powder

Interventions

Freeze-dried black raspberry powderDRUG
Black raspberry powder

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Connecticut Health Center

Farmington, Connecticut, 06030-1845, United States

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

ColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesInflammatory Bowel DiseasesColonic DiseasesIntestinal Diseases

Study Officials

  • Haleh Vaziri, MD

    UConn Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 14, 2014

First Posted

October 17, 2014

Study Start

August 1, 2013

Primary Completion

October 5, 2015

Study Completion

November 13, 2015

Last Updated

April 11, 2017

Record last verified: 2017-04

Locations

US(1)