Lyophilized Black Raspberries in Adults With Familial Adenomatous Polyposis (FAP)
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.
Timeline
- Start
- 2005-12
- Primary completion
- 2008-09
- Completion
- 2008-12
Outcome
Mixed primary results
registry analysis (superiority or other test); All Participants; p = 0.065; Wilcoxon (Mann-Whitney) NCT00770991 ↗
registry analysis (superiority or other test); All Participants; p = 0.043; Wilcoxon (Mann-Whitney) NCT00770991 ↗
registry MEAN Lyophilized BRB Suppositories + BRB Slurry: -5.7 (Standard Deviation 26.6) polyp number x mm NCT00770991 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Background | Black raspberry | Unknown | 20 g | — |
| Background | Black raspberry | Unknown | 730 mg | Rectal |