Adenoma-Carcinoma Sequence in the Ileal Pouch Anal Anastomosis in Patients With Familial Adenomatous Polyposis: Studies on Luminal and Mucosal Risk Factors and Chemoprevention

Radboud University Medical Center2 个研究点分布在 1 个国家目标入组 30 人开始时间: 2006年4月最近更新: 2007年8月10日

适应症

试验速览

阶段: 2 期
发起方: Radboud University Medical Center
入组人数: 30
试验地点: 2
主要终点: Pouch mucosal proliferation index at 0, 1 and 2 months

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to determine whether sulindac and VSL#3 - inulin, either combined or alone, are effective in treating or preventing adenoma development in the ileal anal pouch in patients with familial adenomatous polyposis.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Crossover
主要目的: Prevention
盲法: None

入排标准

年龄范围: 16 Years 至 —（Child, Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Clinically or genetically proven familial adenomatous polyposis
•Restorative proctocolectomy with ileal pouch anal anastomosis

排除标准

•Chronic or acute renal or hepatic disease
•History of oesophageal, gastric or duodenal ulcers
•Known hypersensitivity to sulindac
•Daily use during the last three months of:
•Non-Steroidal Anti-Inflammatory Agents
•Probiotics

结局指标

主要结局

Pouch mucosal proliferation index at 0, 1 and 2 months

Pouch mucosal apoptosis index at 0, 1 and 2 months

次要结局

Pouch mucosal Glutathione S transferases activity and isoenzyme levels at 0, 1 and 2 months
Faecal genotoxicity at 0, 1 and 2 months
Faecal cytotoxicity at 0, 1 and 2 months

研究者

发起方

Radboud University Medical Center

申办方类型

Other

研究点 (2)

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