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

NCT ID: NCT02421705

Last Updated: 2023-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

99999999 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2099-01-31

Brief Summary

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Aim:

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

Detailed Description

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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

Conditions

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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)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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

Group Type OTHER

Sample collection

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Guy Boeckxstaens

Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Guy Boeckxstaens, MD

Role: PRINCIPAL_INVESTIGATOR

Catholic University Leuven and Universitary Hospitals Leuven

Locations

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University Hospitals Leuven

Leuven, Vlaams-Brabant, Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Koen Bellens, MSc

Role: CONTACT

0032-16-341943

Facility Contacts

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Lien Beullens, MSc

Role: primary

0032-16-341943

Dafne Balemans, MSc

Role: backup

0032-16-330158

Other Identifiers

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S51573

Identifier Type: -

Identifier Source: org_study_id

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