Sympatho-vagal Balance in Patients With Irritable Bowel Syndrome, and Evaluation of a Transcutaneous Vagal Nerve Electrical Stimulation on Symptoms and Quality of Life
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 4
- 主要终点
- Improvement of clinical symptoms of IBS, based on the evolution of symptom score (Francis) and symptom scale (UCLA-SSS)
研究概览
简要总结
This pilot study plan to investigate the sympathovagal balance in women affected by Irritable Bowel Syndrome (IBS), and to evaluate the effect of 6 months of trans-cutaneous vagal nerve electrical stimulation on digestive physiology (intestinal transit time, intestinal mucosal permeability, systemic and local inflammation), symptoms and quality of life.
The safety of the electrical stimulation of the left vagal nerve will also be evaluated.
Ten women, age between 18 and 60, will be included.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women aged 18-60,
- •clinical Rome III criteria for IBS
排除标准
- •pregnancy,
- •low intensity symptoms (Francis score between 75-150)
- •IBD, coeliac disease
- •past history of abdominal surgery (appendectomy and cholecystectomy allowed)
- •chronic use of analgesics, anti-depressants
研究组 & 干预措施
Vagal nerve stimulation
Trans-cutaneous vagal nerve electrical stimulation during 6 months
干预措施: Trans-cutaneous vagal nerve electrical stimulation (Device)
结局指标
主要结局
Improvement of clinical symptoms of IBS, based on the evolution of symptom score (Francis) and symptom scale (UCLA-SSS)
时间窗: 3 and 6 months after the beginning of electrical stimulation
次要结局
- Effect of vagal nerve stimulation on quality of life(3 and 6 months)
- Evaluation of sympatho-vagal balance(0, 3 and 6 months)
- Safety and tolerance of trans-cutaneous nerve stimulation as measured by any symptom occurring in relation with electrical stimulation, number of hours per day of system use(6 months)
- Evolution of digestive physiology during vagal nerve stimulation(3 and 6 months)