A Pilot Study To Investigate the Biological Modulation of Familial Adenomatous Polyposis (FAP) by Lyophilized Black Raspberries
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Change From Baseline to End of Study in Number of Rectal Polyps
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Black Raspberry (BRB) Slurry plus BRB suppositories
20 grams BRB Slurry BID plus two, 730 mg BRB suppositories HS
干预措施: Black Raspberry (BRB) Suppositories (Drug)
Black Raspberry (BRB) Slurry plus BRB suppositories
20 grams BRB Slurry BID plus two, 730 mg BRB suppositories HS
干预措施: Black raspberry (BRB) Slurry (Drug)
Black Raspberry (BRB) Placebo Slurry plus BRB suppositories
20 grams BRB Placebo Slurry BID plus two, 730 mg BRB suppositories HS
干预措施: Black Raspberry (BRB) Suppositories (Drug)
Black Raspberry (BRB) Placebo Slurry plus BRB suppositories
20 grams BRB Placebo Slurry BID plus two, 730 mg BRB suppositories HS
干预措施: Black Raspberry (BRB) Placebo Slurry (Drug)
结局指标
主要结局
Change From Baseline to End of Study in Number of Rectal Polyps
时间窗: Baseline and 36 weeks
Change in Burden of Rectal Polyps
时间窗: Baseline and 36 weeks
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.
次要结局
- Apoptosis and Cell Proliferation Measured by Percent Difference in Staining.(baseline and 36 weeks)
研究者
Carol Burke, MD
Principal Investigator
The Cleveland Clinic