Effect of Menstrual Cycle and Irritable Bowel Syndrome on the Central Nervous System Processing of Gut Stimuli
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Sensitivity to rectal distention
研究概览
简要总结
The hypothesis of the study is that women perceive intestinal stimulation (rectal balloon distention) differently in different phases of the menstrual cycle, i.e there is an effect of hormones on the sensory pathway, and that this difference is reflected in the Central Nervous System processing of this signal. We also hypothesize that there is a difference in perception between control subjects and subjects with the irritable bowel syndrome.
详细描述
There is discrepancy in the literature concerning the effect of the menstrual cycle on bowel function and pain syndromes such at irritable bowel syndrome. In addition, recent studies indicate a difference in the CNS processing of rectal stimulation in normal subjects and patients with IBS. This study will determine the differences in the perception of rectal balloon distention in the follicular and luteal phases of the menstrual cycle, in control subjects with no bowel symptoms and volunteers with IBS, and will compare the CNS processing of this signal using functional MRI , again in the two phases of the menstrual cycle.
Comparisons: between control subjects without GI symptoms and those with irritable bowel syndrome.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •controls - normal bowel function
- •Irritable bowel syndrome - Rome II criteria
- •Normal menstrual cycle
排除标准
- •irregular menses
- •pregnancy
- •use of psychotropic medication
- •claustrophobia
- •metal implants
- •metal in eyes
结局指标
主要结局
Sensitivity to rectal distention
时间窗: during the study period only
pressure at which certain sensations are felt when barostat is inflated in the rectum during follicular and luteal phase of menstrual cycle
次要结局
未报告次要终点