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

Not Applicable

Recruiting

• Conditions: Ulcerative Colitis, Active; Crohn's Disease, Remission (6a: With IBS Symptoms, 6b: Without IBS Symptoms); Crohn's Disease, Active; IBS; Healthy Controls; Ulcerative Colitis, Remission (3a: With IBS Symptoms, 3b: Without IBS Symptoms)
• Interventions: Other: Sample collection

• Registration Number: NCT02421705
• Lead Sponsor: KU Leuven

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

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2013-07-31
• Study First Submitted QC: 2015-04-20
• Study First Posted: 2015-04-21
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-07
• Last Update Posted: 2023-02-08
• Primary Completion: 2099-01
• Study Completion: 2099-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 99999999

Inclusion Criteria

For group 1: IBS

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

For all groups:

1. co-morbidity: severe kidney- and/or liver disease or thyroid abnormalities and impaired clotting
2. Abdominal chirurgy (except for an uncomplicated appendectomy)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sample collection	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

Primary Outcome Measures

Name	Time	Method
differences in visceral sensitivity in different study groups (Visceral sensitivity will me measured by performing a rectal barostat test)	at time of investigation (rectal barostat test), Day 1	Visceral sensitivity will me measured by performing a rectal barostat test

Secondary Outcome Measures

Name	Time	Method
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	measuring release of mest cell mediators in rectal biopsies, measuring parameters of immune activity in blood (for example by stimulating Peripheral Blood Mononuclear Cells)

Trial Locations

Locations (1)

University Hospitals Leuven; 🇧🇪 Leuven, Vlaams-Brabant, Belgium