Phase 1 N=24 Randomized Prevention

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

Familial Adenomatous Polyposis

Bottom Line

View on ClinicalTrials.gov: NCT00770991 ↗

Enrolled (actual)

Serious AEs

4.2%

Results posted

Feb 2016

Primary outcome: Primary: Change From Baseline to End of Study in Number of Rectal Polyps — -5.4; -1.6; -3.5 polyps — p=0.065

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: Black raspberry (BRB) Slurry (Drug); Black Raspberry (BRB) Suppositories (Drug); Black Raspberry (BRB) Placebo Slurry (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: The Cleveland Clinic
Primary completion: Sep 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline to End of Study in Number of Rectal Polyps	-5.4; -1.6; -3.5	0.065
PRIMARY Change in Burden of Rectal Polyps	-13; -5.7; -9.4	0.043 sig
SECONDARY Apoptosis and Cell Proliferation Measured by Percent Difference in Staining.	11.3; 55.2; 8.00; 49.12; -3.30; -6.08	0.016 sig

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.

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00770991). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.