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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00770991
Other study ID # 2003-34501-13965
Secondary ID
Status Completed
Phase Phase 1
First received October 9, 2008
Last updated February 11, 2016
Start date December 2005
Est. completion date December 2008

Study information

Verified date February 2016
Source The Cleveland Clinic
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

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.


Recruitment information / eligibility

Status Completed
Enrollment 34
Est. completion date December 2008
Est. primary completion date September 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

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


Intervention

Drug:
Black raspberry (BRB) Slurry
20 grams BRB Slurry
Black Raspberry (BRB) Suppositories
Two, 730 mg BRB suppositories QHS
Black Raspberry (BRB) Placebo Slurry
20 grams BRB placebo slurry

Locations

Country Name City State
United States Cleveland Clinic Cleveland Ohio

Sponsors (2)

Lead Sponsor Collaborator
The Cleveland Clinic Ohio State University Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change From Baseline to End of Study in Number of Rectal Polyps Baseline and 36 weeks No
Primary Change in Burden of Rectal Polyps The burden was measured as the sum of the number of polyps x size of polyps in mm. The change in burden was determined between baseline and 36 weeks. Baseline and 36 weeks No
Secondary Apoptosis and Cell Proliferation Measured by Percent Difference in Staining. A pooled analysis of all participants was used for biomarker results. Tissue from normal mucosa and rectal polyps were obtained to assay KI 67 (proliferation) and TUNEL at baseline and end of treatment. A decrease in the value of KI 67 implies lower proliferation while an increase in TUNEL is suggestive of an increase in apoptosis. baseline and 36 weeks No
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