NCT02421705招募中不适用
Visceral Sensitivity in IBD and IBS: Role of Inflammation, Immune Activity and Genetic Factors
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- KU Leuven
- 入组人数
- 99,999,999
- 试验地点
- 2
- 主要终点
- differences in visceral sensitivity in different study groups (Visceral sensitivity will me measured by performing a rectal barostat test)
研究概览
简要总结
Aim:
More insight in pathogenesis of IBS and IBD. Samples are collected in context of an European research project.
详细描述
Methods:
Sample collection in healthy subjects, IBD and IBS patients:
- biopsy of rectum and colon descendens
- blood sample collection
- collection of sample of nasal mucosa
- feces collection
- questionnaires
- rectal barostat sensitivity measurement
- transit measurement of colon
- MR scan of brain
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- •For group 1: IBS
- •Irritable Bowel Syndrome (IBS) (ROME III criteria)
- •No obvious organic explanation for the IBS symptoms
- •Medication which affects the gastrointestinal motility or perception should be stopped at least 24 hours before the study
- •Group 2: active ulcerative colitis
- •diagnosis of ulcerative colitis (Confirmed by at least one sigmoidoscopy)
- •Medication which affects the gastrointestinal motility or perception should be stopped at least 24 hours before the study
- •Group 3: ulcerative colitis in remission (3a: with IBS symptoms, 3b: without IBS symptoms)
- •diagnosis of ulcerative colitis (Confirmed by at least one sigmoidoscopy)
- •remission is confirmed by at least one sigmoidoscopy
- •Medication which affects the gastrointestinal motility or perception should be stopped at least 24 hours before the study
- •Only for group 3a:
- •Rome III criteria for IBS
- •Group 4: Healthy controls No abdominal (pain) complaints.
- •Group 5: active Crohn's disease
- •diagnosis of Crohn's disease (Confirmed by at least one sigmoidoscopy)
- •Medication which affects the gastrointestinal motility or perception should be stopped at least 24 hours before the study
- •Group 6: Crohn's disease in remission (6a: with IBS symptoms, 6b: without IBS symptoms)
- •diagnosis of Crohn's disease (Confirmed by at least one sigmoidoscopy)
- •remission is confirmed by at least one sigmoidoscopy
- •Medication which affects the gastrointestinal motility or perception should be stopped at least 24 hours before the study
排除标准
- •For all groups:
- •co-morbidity: severe kidney- and/or liver disease or thyroid abnormalities and impaired clotting
- •Abdominal chirurgy (except for an uncomplicated appendectomy)
结局指标
主要结局
differences in visceral sensitivity in different study groups (Visceral sensitivity will me measured by performing a rectal barostat test)
时间窗: at time of investigation (rectal barostat test), Day 1
Visceral sensitivity will me measured by performing a rectal barostat test
次要结局
- immune activity (measuring release of mest cell mediators in rectal biopsies, measuring parameters of immune activity in blood)(at time of investigation (rectal biopsy), Day 1)
研究者
研究点 (2)
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