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

Familial Adenomatous Polyposis Clinical Trial

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

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00770991
Study type Interventional
Source The Cleveland Clinic
Contact
Status Completed
Phase Phase 1
Start date December 2005
Completion date December 2008
View Details
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