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

Healthy Controls Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02421705
• Other study ID #: S51573
• Status: Recruiting
• Phase: N/A
• Start date: February 2010
• Est. completion date: January 2099

Study information

• Verified date: February 2023
• Source: KU Leuven
• Contact: Koen Bellens, MSc
• Phone: 0032-16-341943
• Email: koen.bellens[@]kuleuven.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Aim:

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 99999999
• Est. completion date: January 2099
• Est. primary completion date: January 2099
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Belgium	University Hospitals Leuven	Leuven	Vlaams-Brabant

Sponsors (1)

Lead Sponsor	Collaborator
KU Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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