NCT00749905终止2 期
A Prospective Randomized Controlled Investigator-blinded Study of Low Fiber Diet for Bowel Preparation for Colon Capsule Examination
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Colon cleanliness
研究概览
简要总结
A prospective randomized controlled investigator-blinded study to compare efficacy of low fiber diet for 5 days versus regular diet, both as adjunct to one day clear liquid diet and standard bowel preparation for colon capsule examination
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >18 and <75
- •Colon study indicated for colo-rectal carcinoma screening
- •After colonoscopy for any indication failed due to technical causes
- •Patients who decline an indicated colonoscopy
排除标准
- •Significant heart failure (NYHA grade III-IV)
- •Renal failure (Creatinine > 1.2 mg/dl)
- •Known or suspected intestinal strictures
- •Known or suspected mesenteric adhesions
- •History suggestive of bowel obstruction
- •Vomiting and/or aspirations
- •Symptoms of dysphagia
- •Pace-maker or AICD implanted
- •Known allergy or intolerance to any of the study drugs
- •Pregnancy
- •Illicit drug abuse or alcoholism
- •Inability to provide an informed consent
研究组 & 干预措施
1
Experimental
Low fiber diet for 5 days prior to procedure
干预措施: low fiber diet (Other)
2
Active Comparator
regular diet
干预措施: regular diet (Other)
结局指标
主要结局
Colon cleanliness
时间窗: one week from capsule examination
次要结局
- Tolerability of preparations(within 1 day of completing preparation)
研究者
Prof. Shomron BenHorin
Professor
Sheba Medical Center
研究点 (1)
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