The Effect of Chewing Gum on Small Bowel Transit Time: a Prospective Randomized Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 122
- 试验地点
- 1
- 主要终点
- Small bowel transit time
研究概览
简要总结
The purpose of this study is to see if chewing sugarless chewing gum alters the time it takes for a capsule endoscopy to travel through the stomach and small bowel, and to see if more/less capsule endoscopes reach the large bowel.
详细描述
The subjects will include patients already referred to us for a capsule endoscopy (CE) in this unit. We have calculated how many patients we need from small bowel transit times from the last 100 patients who had a CE at our centre. We will include 122. These will be randomly divided into two groups. The patients (chew chewing gum) and the controls (do not chew chewing gum).
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 (Participant)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All out-patients > 19 years old presenting for capsule endoscopy
排除标准
- •Patients on narcotics
- •Patients on motility enhancing and/or slowing drugs should stop these at least 5 days prior to the procedure or be excluded from the study.
- •Patients, who have proven or suspected obstruction of the bowel.
- •Patients, who have had prior small bowel and/or gastric surgery.
- •Patients with an ileostomy.
- •Patients who have a known and/or have a history of swallowing disorder
- •Patients with diabetes and/or hypo-/hyper- thyroidism
- •Patients in whom the capsule become impacted at a stricture (these patients will be taken out of the study and given the necessary medical/surgical treatment).
研究组 & 干预措施
1.
The subject group will chew sugarless chewing gum for a specific amount of time while undergoing capsule endoscopy.
干预措施: Trident sugarless chewing gum. (Other)
2.
The control group will not chew chewing gum while undergoing capsule endoscopy.
干预措施: One control group (these do not chew gum). (Other)
结局指标
主要结局
Small bowel transit time
时间窗: 6 hours
次要结局
- Gastric transit time, cecal completion rate(6 hours)