Visceral Sensitivity in IBD (Irritable Bowel Disease) and IBS (Irritable Bowel Syndrome)

Study Overview
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Brief Summary
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Aim: More insight in pathogenesis of IBS and IBD. Samples are collected in context of an European research project.

Detailed Description
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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

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

Conditions
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Healthy Controls, IBS, Ulcerative Colitis, Active, Ulcerative Colitis, Remission (3a: With IBS Symptoms, 3b: Without IBS Symptoms), Crohn's Disease, Active, Crohn's Disease, Remission (6a: With IBS Symptoms, 6b: Without IBS Symptoms)

Intervention / Treatment
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* Other: Sample collection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 1. diagnosis of ulcerative colitis (Confirmed by at least one sigmoidoscopy) 3. 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 1. diagnosis of Crohn's disease (Confirmed by at least one sigmoidoscopy) 3. 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 Exclusion Criteria: For all groups: co-morbidity: severe kidney- and/or liver disease or thyroid abnormalities and impaired clotting Abdominal chirurgy (except for an uncomplicated appendectomy)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Sample collection<br>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 | Other: Sample collection<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| differences in visceral sensitivity in different study groups (Visceral sensitivity will me measured by performing a rectal barostat test) | Visceral sensitivity will me measured by performing a rectal barostat test | at time of investigation (rectal barostat test), Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| immune activity (measuring release of mest cell mediators in rectal biopsies, measuring parameters of immune activity in blood) | measuring release of mest cell mediators in rectal biopsies, measuring parameters of immune activity in blood (for example by stimulating Peripheral Blood Mononuclear Cells) | at time of investigation (rectal biopsy), Day 1 |