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

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

Aim:

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

Study Overview

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

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 Type: Interventional
• Enrollment (Anticipated): 99999999
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Koen Bellens, MSc; Phone Number: 0032-16-341943; Email: koen.bellens@kuleuven.be

Study Locations

• Belgium
  • Vlaams-Brabant
    • Leuven, Vlaams-Brabant, Belgium, 3000
      • Recruiting
      • University Hospitals Leuven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	at time of investigation (rectal barostat test), Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	at time of investigation (rectal biopsy), Day 1

Collaborators and Investigators

• Sponsor: KU Leuven

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (ANTICIPATED): January 1, 2099
• Study Completion (ANTICIPATED): January 1, 2099

Study Registration Dates

• First Submitted: July 31, 2013
• First Submitted That Met QC Criteria: April 20, 2015
• First Posted (ESTIMATE): April 21, 2015

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 7, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer; Crohn Disease; Colitis; Colitis, Ulcerative
• Other Study ID Numbers: S51573