CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 34 enrolled
Drug / intervention
Black raspberry (BRB) Slurry +2 moredrug
Likely dose
Black Raspberry (BRB) Suppositories 730 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00770991
NCT00770991Phase 1Completed
CompareCT.gov

A Pilot Study To Investigate the Biological Modulation of Familial Adenomatous Polyposis (FAP) by Lyophilized Black Raspberries

The Cleveland Clinic·interventional·Posted Oct 10, 2008·Updated Feb 15, 2016

In Brief

A Phase 1 clinical trial evaluating Black raspberry (BRB) Slurry, Black Raspberry (BRB) Suppositories, and 1 other intervention for Familial Adenomatous Polyposis. Completed, enrolled 34 participants across 1 site.

Detailed Summary

This is a 36 week dietary intervention pilot study to evaluate the effects of lyophilized black raspberries on rectal polyp burden and biomarkers in subjects with FAP. Subjects will undergo a colonoscopy or sigmoidoscopy before study treatment to determine eligibility for the study. Eligible participants will undergo a sigmoidoscopy at 36 weeks after the initiation of study treatment. The size and number of rectal polyps will be documented on a code sheet and by photograph. The efficacy outcome will include the percentage reduction in the number of rectal polyps between baseline and 36 weeks.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFamilial Adenomatous Polyposis
CountriesUnited States
CollaboratorsOhio State University Comprehensive Cancer Center

Timeline

Phase 1CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 10, 2008
Enrollment StartDec 1, 2005
Primary CompletionSep 1, 2008
Study CompletionDec 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 17.7 years ago

Interventions

Black raspberry (BRB) Slurrydrug

20 grams BRB Slurry

Black Raspberry (BRB) Suppositoriesdrug

Two, 730 mg BRB suppositories QHS

Black Raspberry (BRB) Placebo Slurrydrug

20 grams BRB placebo slurry