Visceral Sensitivity in IBD (Irritable Bowel Disease) and IBS (Irritable Bowel Syndrome)
NCT ID: NCT02421705
Last Updated: 2023-02-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
99999999 participants
INTERVENTIONAL
2010-02-28
2099-01-31
Brief Summary
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More insight in pathogenesis of IBS and IBD. Samples are collected in context of an European research project.
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Detailed Description
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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
Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Sample collection
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
Sample collection
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
Interventions
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Sample collection
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
Eligibility Criteria
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Inclusion Criteria
1. Irritable Bowel Syndrome (IBS) (ROME III criteria)
2. No obvious organic explanation for the IBS symptoms
3. 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)
1. diagnosis of ulcerative colitis (Confirmed by at least one sigmoidoscopy)
2. remission is 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
Only for group 3a:
4. 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)
1. diagnosis of Crohn's disease (Confirmed by at least one sigmoidoscopy)
2. remission is 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
Exclusion Criteria
1. co-morbidity: severe kidney- and/or liver disease or thyroid abnormalities and impaired clotting
2. Abdominal chirurgy (except for an uncomplicated appendectomy)
18 Years
65 Years
ALL
Yes
Sponsors
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KU Leuven
OTHER
Responsible Party
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Guy Boeckxstaens
Prof. Dr.
Principal Investigators
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Guy Boeckxstaens, MD
Role: PRINCIPAL_INVESTIGATOR
Catholic University Leuven and Universitary Hospitals Leuven
Locations
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University Hospitals Leuven
Leuven, Vlaams-Brabant, Belgium
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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S51573
Identifier Type: -
Identifier Source: org_study_id
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