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临床试验/NCT02421705
NCT02421705招募中不适用

Visceral Sensitivity in IBD and IBS: Role of Inflammation, Immune Activity and Genetic Factors

KU Leuven2 个研究点 分布在 1 个国家目标入组 99,999,999 人开始时间: 2010年2月最近更新:
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

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

发起方
KU Leuven
申办方类型
Other
责任方
Principal Investigator
主要研究者

Guy Boeckxstaens

Prof. Dr.

KU Leuven

研究点 (2)

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