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

Catholic University (KU) of Leuven

Status: Enrolling

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

Treatments: Other: Sample collection

Study type: Interventional

Funder types: Other

Identifiers

NCT02421705

S51573

Details and patient eligibility

About

Aim:

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

Full 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

Enrollment: 99,999,999 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts 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)

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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99,999,999 participants in 1 patient group

Sample collection

Other group

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

Treatment:

Other: Sample collection