Lyophilized Black Raspberries in Adults With Familial Adenomatous Polyposis (FAP)
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Enrollment
Sex
Ages
Volunteers
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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
34 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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