NCT00603707已完成不适用
Assessment of Whole Gut Transit Time Using the SmartPill Capsule: a Multi-Center Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 178
- 试验地点
- 8
- 主要终点
- whole gut transit time
研究概览
简要总结
Our null hypothesis states that the two techniques (Sitzmarks radioopaque markers and SmartPill) are equivalent and is demonstrated if the study population shows a correlation of 0.7 or higher.
详细描述
The purpose of the study is to measure total gastrointestinal transit time using SmartPill GI Monitoring System with pH.p Capsule and compare the transit time determined by capsule transit to the conventional radioopaque marker technique.
Both techniques are simultaneously applied in normal and constipated adult populations.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females between ages of 18-80 years of age with functional constipation that fulfills the Rome II definition of functional constipation
- •Bowel movement frequency of < 3 times per week but at least once per two weeks.
- •Constipation symptoms for at least 1 year duration.
- •Constipation, not abdominal pain, as the primary symptom.
- •Ability to stop fiber, laxatives, prokinetic agents, and narcotic analgesic agents 3 days prior to the study and during the 5 day study period.
- •Ability to stop proton pump inhibitors 7 days prior to the study and H2RAs for 3 days prior to the study.
排除标准
- •Previous history of bezoars.
- •Prior GI surgery except for cholecystectomy, appendectomy, or Nissen fundoplication
- •Any abdominal surgery within the past 3 months
- •Known or history of inflammatory bowel disease
- •History of diverticulitis, diverticular stricture, and other intestinal strictures
- •Tobacco use within eight hours prior to capsule ingestion and during the initial 8 hour recording on Day 0 or the Ingestion visit.
- •Alcohol use within eight hours prior to capsule ingestion and throughout the entire monitoring period (5 days).
- •BMI > 38
- •Allergies to components of the SmartBar (Appendix IX).
- •Females of childbearing age who are not practicing birth control and/or are pregnant or lactating. (A urine pregnancy test will be performed on female subjects prior to capsule ingestion).
- •Cardiovascular, endocrine, renal, or other chronic disease likely to affect motility.
- •Use of medical devices such as pacemakers, infusion pumps, or insulin pumps.
- •Any contraindication to use of Fleets Enema or balloon expulsion test.
- •Uncontrolled diabetes with a hemoglobin A1C greater than 10.
结局指标
主要结局
whole gut transit time
时间窗: 2 days and 5 days
次要结局
- Determine regional gut (gastric, small bowel, colonic) transit times(continuous time measure until caspule elimination)
研究者
研究点 (8)
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