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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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02421705
Enrollment
99999999
Registered
2015-04-21
Start date
2010-02-28
Completion date
2099-01-31
Last updated
2023-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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

Interventions

OTHERSample 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

Sponsors

KU Leuven
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
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 1Visceral sensitivity will me measured by performing a rectal barostat test

Secondary

MeasureTime frameDescription
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 1measuring release of mest cell mediators in rectal biopsies, measuring parameters of immune activity in blood (for example by stimulating Peripheral Blood Mononuclear Cells)

Countries

Belgium

Contacts

Primary ContactKoen Bellens, MSc
koen.bellens@kuleuven.be0032-16-341943

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026