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

Completed · Phase 1 · Has a placebo group

Conditions studied: Familial Adenomatous Polyposis

In brief

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.

Key facts

Study ID

NCT00770991

Run by

The Cleveland Clinic

People needed

34

Starts

2005-12-01

Expected to finish

2008-12-01

Last updated by the study team

2016-02-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Cleveland Clinic — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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