Anorectal Function and Neuronal-glial-epithelial Unit in Healthy Subjects
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Number of enteric neurons per ganglion
研究概览
简要总结
This study aims to assess the phenotype of the enteric nervous system (enteric neurons) in healthy subjects.
The enteric nervous system (ENS) is composed by enteric neurons and enteric glial cells. There is a cross-talk between ENS and the intestinal epithelial barrier (IEB). ENS and IEB together constitute the neuronal-glial-epithelial unit. This unit has a key role in gut functions. The characteristics and the phenotype of the ENS also change according to age and environmental factors. Similar study is ongoing for patients with Spina Bifida. Anorectal data and phenotype of the neuronal-glial-epithelial unit in healthy subjects is required to assess abnormality of these items in patients with neurological disease including Spina Bifida.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •subject aged between 18 and 65 years old age and sex matched with the first sixteen patients included and evaluated in the ANOSPIN study
- •subject who gave their written consent to participate to the present study
- •subject not included in another study
- •subject covered by social insurance system
排除标准
- •Pregnant or nursing women;
- •Anticoagulants therapy or coagulation disorders;
- •Past history of anal or rectal surgery
- •Crohn disease or ulcerative colitis
- •Irritable bowel syndrome according to the Rome III criteria;
- •Past history of pelvic radiotherapy
- •Pas history of rectal or anal cancer
- •Anorectal symptoms : faecal incontinence, constipation, anorectal pain, rectal prolapse;
- •CCIS >5 (faecal incontinence);
- •Kess Score >9 (constipation);
- •Colonic irrigation;
- •Use of laxatives;
- •Abnormal colonic mucosa
- •Period of exclusion;
- •Patient under guardianship or unable to give their consent;
结局指标
主要结局
Number of enteric neurons per ganglion
时间窗: data collected at the day of endoscopy
colonic biopsies will be used to study intestinal permeability, colonic inflammation and enteric nervous system
次要结局
- density and activity of the enteric glial cells(data collected at the day of endoscopy)
- rectal adaptation(data collected at the day of endoscopy)
- rectal perception(data collected at the day of endoscopy)
- anal distensiblity(data collected at the day of endoscopy)
- intestinal permeability(data collected at the day of endoscopy)
- macroscopic and microscopic colonic inflammation(data collected at the day of endoscopy)