NCT02421705招募中不适用
Visceral Sensitivity in IBD and IBS: Role of Inflammation, Immune Activity and Genetic Factors
适应症
干预措施
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
- 1
- 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)
研究组 & 干预措施
Sample collection
Other
Collection of blood, feces samples, sample of nasal mucosa and biopsies (rectum and colon descendens), questionnaires and performance of rectal sensitivity measurement (barostat), MR scan of brain and transit measurement of colon
干预措施: Sample collection (Other)
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 (1)
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