Clinical trial NCT02421705: 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
Overall status: RECRUITING
Phase: NA
Conditions: 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)
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2015-04-21
Enrollment: 99999999
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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

Eligibility criteria: 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)

Primary outcomes:
measure: differences in visceral sensitivity in different study groups (Visceral sensitivity will me measured by performing a rectal barostat test)
timeFrame: at time of investigation (rectal barostat test), Day 1
Secondary outcomes:
measure: immune activity (measuring release of mest cell mediators in rectal biopsies, measuring parameters of immune activity in blood)
timeFrame: at time of investigation (rectal biopsy), Day 1
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospitals Leuven
state: Vlaams-Brabant
Study officials:
affiliation: Catholic University Leuven and Universitary Hospitals Leuven
name: Guy Boeckxstaens, MD
role: PRINCIPAL_INVESTIGATOR
References: