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

Sponsor

KU Leuven (Other)

Overall Status

Recruiting

CT.gov ID

NCT02421705

Collaborator

(none)

99,999,999

Enrollment

Location

Arm

1067

Duration (Months)

93723.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Aim:

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

Condition or Disease	Intervention/Treatment	Phase
IBS 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)	Other: Sample collection	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

99999999 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

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

Study Start Date :

Feb 1, 2010

Anticipated Primary Completion Date :

Jan 1, 2099

Anticipated Study Completion Date :

Jan 1, 2099

Arms and Interventions

Arm	Intervention/Treatment
Other: 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	Other: 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

Arm

Intervention/Treatment

Other: 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

Other: Sample collection

Outcome Measures

Primary Outcome Measures

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

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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospitals Leuven	Leuven	Vlaams-Brabant	Belgium	3000

Sponsors and Collaborators

KU Leuven

Investigators

Principal Investigator: Guy Boeckxstaens, MD, Catholic University Leuven and Universitary Hospitals Leuven

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Guy Boeckxstaens, Prof. Dr., KU Leuven

ClinicalTrials.gov Identifier:

NCT02421705

Other Study ID Numbers:

S51573

First Posted:

Apr 21, 2015

Last Update Posted:

Feb 8, 2017

Last Verified:

Feb 1, 2017

Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 8, 2017