Lyophilized Black Raspberries in Adults With Familial Adenomatous Polyposis (FAP)



Status:Completed
Conditions:Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:December 2005
End Date:December 2008

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Trial Summary
Trial Overview
Inclusion Criteria

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

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.


Inclusion Criteria:

- Diagnosis of familial adenomatous polyposis with at least 5 rectal polyps which are
greater than or equal to 2 mm on baseline colonoscopy

- Have an endoscopically assessable rectal segment

- Have not taken NSAIDs or selective COX-2 inhibitors for two months prior to the study
and willing to remain off NSAIDs for the study duration.

Exclusion Criteria:

- Known allergies or hypersensitivity to berries

- Diabetes mellitus

- Subjects taking NSAIDs or COX-2 inhibitors who cannot be taken off the medication due
to their clinical condition.
We found this trial at
1
site
Cleveland Clinic
9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
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