Gastrointestinal Transit Times and Motility in Patients Suffering From Severe Ulcerative Colitis Obtained by Motilis-3D-transit
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Velocity of progression through the inflamed part of the colon in severe UC compared to the velocity of progression in the corresponding colonic segment in healthy volunteers.
研究概览
简要总结
The purpose of this study is to describe gastrointestinal (GI) motility in patients suffering from severe Ulcerative Colitis (UC) and to compare these results with similar results from a study on healthy subjects.
Both studies are done with the use of Motilis 3D-Transit system which consists of a small electronic capsule ingested and detected by a receiver carried by the patient. Position and orientation of the capsule are interpreted by dedicated computer software and transit times, progression velocity and contraction frequencies can be revealed.
The study is mainly descriptive and is designed to test and evaluate the usefulness of the Motilis 3D Transit system in UC patients and to tell us more about GI motility during severe inflammation.
Motilis 3D-Transit system gives us a unique chance to study the gastrointestinal canal as a whole during severe illness.
We expect to include 20 patients suffering from severe UC admitted to Hospital with the purpose of getting medical treatment. We do not expect any drop out, but in case of drop out a new patient will be included.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Severe Ulcerative colitis (modified Truelove and Witt score)
- •Signed informed consent obtained
- •Fasted since midnight
排除标准
- •Known GI related symptoms complaints or GI diseases
- •Swallowing disorders
- •Cancer or other life threatening diseases or conditions
- •Pregnancy or breast-feeding
- •Previous abdominal surgery
- •Abdominal diameter >140cm?
- •Drug abuse or alcoholism
- •Irregular bowel movements
- •Known cardiovascular or pulmonary diseases
- •Participation in any clinical study within the last 30 days
- •Cardiac pacemaker or infusion pump or any other implanted or portable electro-mechanical medical device.
- •Medication affecting GI motility
- •MRI within the next four weeks
结局指标
主要结局
Velocity of progression through the inflamed part of the colon in severe UC compared to the velocity of progression in the corresponding colonic segment in healthy volunteers.
时间窗: Three days from baseline visit
次要结局
- Velocity of progression through the non-inflamed colonic segments in severe UC compared to the velocity of progression in the corresponding colonic segments in healthy volunteers.(Three days from baseline)