Trial Information
A Pilot Study To Investigate the Biological Modulation of Familial Adenomatous Polyposis (FAP) by Lyophilized Black Raspberries
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
Outcome Measure:
To determine whether daily exposure of Black Raspberries reduces the number of rectal polyps in subjects with FAP.
Outcome Time Frame:
36 weeks
Safety Issue:
Yes
Principal Investigator
Carol A Burke, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
The Cleveland Clinic
Authority:
United States: Food and Drug Administration
Study ID:
2003-34501-13965
NCT ID:
NCT00770991
Start Date:
December 2005
Completion Date:
December 2008
Related Keywords:
- Familial Adenomatous Polyposis
- Polyp, Familial Adenomatous Polyposis, Prevention
- Adenomatous Polyposis Coli
- Colorectal Neoplasms
- Nasopharyngeal Neoplasms
Name | Location |
Cleveland Clnic |
Cleveland, Ohio 44195 |