Efficacy of Wholistic Turmeric Supplementation on Polyp Number and Size in Patients With Familial Adenomatous Polyposis A Randomized, Double Blinded, Placebo Controlled Study
试验速览
- 阶段
- 2 期
- 入组人数
- 40
- 主要终点
- Size of polyps
研究概览
简要总结
A Phase 2, randomized, double blind, placebo controlled trial for the effectivness of wholistic turmeric supplementation on polyp burden mong patients with Familial Adenomatouse Polyposis (FAP). Fourty Patients will be randomly assigned in a 1:1 ratio to recieve treatment with 8 capsuls (2*4 capsuls/day) of wholistic Turmeric capsules (Pukka herbs) or placebo for six months.
详细描述
Fourty individuals with identified APC mutation or MUTYH mutation that result in a phenotype of multiple colonic adenomas with or without duodenal adenomas will be included in the study. Participants will be allocated in a 1:1 ratio to receive either wholistic Turmeric capsules (Pukka herbs) or placebo for 6 months.
Participants will be assessed by a gastroenterologist 4-8 weeks after initiation, and at termination/conclusion visit at 6 months.
Blood, stool and urine samples will be collected at baseline, after 4-8 weeks and at 6 months just before final colonoscopy.
Serum samples will be used for testing complete blood count, liver function test, C-reactive protein (CRP) Various cytokines and small molecule measurements. Stool samples will be evaluated for microbiome composition.
Curcumin and curcuminoid levels will be measured in tissue serum, stool and urine will be measured in a subsample of patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Placebo and curcumin capsules are identical in appearance, and will be marked as "A" or "B". Study participants and staff will be blinded to the capsule content. A locked file containing the description will remain in a locked file on the study coordinators computer.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •An established clinical diagnosis of Familial Polyposis based on accepted clinical/ endoscopic and an identified APC or MUTYH mutation
- •Age 18-70 years.
- •Willing and able to give written consent.
- •At least 5 polyps, 2mm or lrager, with at least one larger then 4mm but not more then 20mm.
- •Colonic polyp burden that can be estimated by either counting or photographing(photo or video).
- •Exclusion criteria:
- •Pregnant or nursing women.
- •Stable does of any COX inhibitor drugs for more than 3 months prior to study entry,.
- •Concomitant severe or uncontrolled cardiovascular, hepatic, renal or metabolic disease.
- •Known allergy to curcumin.
- •Anticipated surgery within 6 months
- •Diagnosed polyps of high grade dysplasia or of adenocarcinomas in the GI on screening colonoscopy.
排除标准
- 未提供
结局指标
主要结局
Size of polyps
时间窗: 6 months
Number of polyps
时间窗: 6 months
次要结局
- Histological proliferation assays in frozen polyps and normal tissue (such as KI67, caspase 3 activity and COX-2 expression).(6 months)
- Duodenal adenoma size.(6 months)
- Curcumin and curcuminoid levels in urine.(6 months)
- Colonic microbiome composition, after curcumin therapy.(6 months)
- Histological apoptosis assays in frozen polyps and normal tissue (such as KI67, caspase 3 activity and COX-2 expression).(6 months)
- Duodenal adenoma number.(6 months)
- Curcumin and curcuminoid levels in blood.(6 months)
研究者
michal roll
Head of Research and Development department
Tel-Aviv Sourasky Medical Center