A Pilot Study To Investigate the Biological Modulation of Familial Adenomatous Polyposis (FAP) by Lyophilized Black Raspberries
- 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.
- 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.
Type of Study:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
To determine whether daily exposure of Black Raspberries reduces the number of rectal polyps in subjects with FAP.
Outcome Time Frame:
Carol A Burke, MD
The Cleveland Clinic
United States: Food and Drug Administration
- Familial Adenomatous Polyposis
- Polyp, Familial Adenomatous Polyposis, Prevention
- Adenomatous Polyposis Coli
- Colorectal Neoplasms
- Nasopharyngeal Neoplasms
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