search
Back to results

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

Primary Purpose

IBS, Ulcerative Colitis, Active, Ulcerative Colitis, Remission (3a: With IBS Symptoms, 3b: Without IBS Symptoms)

Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Sample collection
Sponsored by
KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for IBS

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • University Hospitals LeuvenRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Sample collection

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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)

Full Information

First Posted
July 31, 2013
Last Updated
February 7, 2023
Sponsor
KU Leuven
search

1. Study Identification

Unique Protocol Identification Number
NCT02421705
Brief Title
Visceral Sensitivity in IBD (Irritable Bowel Disease) and IBS (Irritable Bowel Syndrome)
Official Title
Visceral Sensitivity in IBD and IBS: Role of Inflammation, Immune Activity and Genetic Factors
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 2010 (undefined)
Primary Completion Date
January 2099 (Anticipated)
Study Completion Date
January 2099 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
KU Leuven

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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)

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
99999999 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sample collection
Arm Type
Other
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Sample collection
Intervention Description
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 Measure Information:
Title
differences in visceral sensitivity in different study groups (Visceral sensitivity will me measured by performing a rectal barostat test)
Description
Visceral sensitivity will me measured by performing a rectal barostat test
Time Frame
at time of investigation (rectal barostat test), Day 1
Secondary Outcome Measure Information:
Title
immune activity (measuring release of mest cell mediators in rectal biopsies, measuring parameters of immune activity in blood)
Description
measuring release of mest cell mediators in rectal biopsies, measuring parameters of immune activity in blood (for example by stimulating Peripheral Blood Mononuclear Cells)
Time Frame
at time of investigation (rectal biopsy), Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Koen Bellens, MSc
Phone
0032-16-341943
Email
koen.bellens@kuleuven.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guy Boeckxstaens, MD
Organizational Affiliation
Catholic University Leuven and Universitary Hospitals Leuven
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospitals Leuven
City
Leuven
State/Province
Vlaams-Brabant
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lien Beullens, MSc
Phone
0032-16-341943
Email
lien.beullens@kuleuven.be
First Name & Middle Initial & Last Name & Degree
Dafne Balemans, MSc
Phone
0032-16-330158
Email
dafne.balemans@med.kuleuven.be

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs