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

KU Leuven1 site in 1 country99,999,999 target enrollmentFebruary 2010

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

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: IBS
Sponsor: KU Leuven
Enrollment: 99999999
Locations: 1
Primary Endpoint: differences in visceral sensitivity in different study groups (Visceral sensitivity will me measured by performing a rectal barostat test)
Status: Recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Aim:

More insight in pathogenesis of IBS and IBD. Samples are collected in context of an European research project.

Detailed Description

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

Registry

clinicaltrials.gov

Start Date

February 2010

End Date

January 2099

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

KU Leuven

Responsible Party

Principal Investigator

Guy Boeckxstaens

Prof. Dr.

KU Leuven

Eligibility Criteria

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
•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

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)

Outcomes

Primary Outcomes

differences in visceral sensitivity in different study groups (Visceral sensitivity will me measured by performing a rectal barostat test)

Time Frame: at time of investigation (rectal barostat test), Day 1

Visceral sensitivity will me measured by performing a rectal barostat test

Secondary Outcomes

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)