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Clinical Trials/NCT02421705
NCT02421705RecruitingNot Applicable

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

KU Leuven2 sites in 1 country99,999,999 target enrollmentStarted: February 2010Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
KU Leuven
Enrollment
99,999,999
Locations
2
Primary Endpoint
differences in visceral sensitivity in different study groups (Visceral sensitivity will me measured by performing a rectal barostat test)
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Basic Science
Masking
None

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •For group 1: IBS
  • •Irritable Bowel Syndrome (IBS) (ROME III criteria)
  • •No obvious organic explanation for the IBS symptoms
  • •Medication which affects the gastrointestinal motility or perception should be stopped at least 24 hours before the study
  • •Group 2: active ulcerative colitis
  • •diagnosis of ulcerative colitis (Confirmed by at least one sigmoidoscopy)
  • •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)
  • •diagnosis of ulcerative colitis (Confirmed by at least one sigmoidoscopy)
  • •remission is confirmed by at least one sigmoidoscopy
  • •Medication which affects the gastrointestinal motility or perception should be stopped at least 24 hours before the study
  • •Only for group 3a:
  • •Rome III criteria for IBS
  • •Group 4: Healthy controls No abdominal (pain) complaints.
  • •Group 5: active Crohn's disease
  • •diagnosis of Crohn's disease (Confirmed by at least one sigmoidoscopy)
  • •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)
  • •diagnosis of Crohn's disease (Confirmed by at least one sigmoidoscopy)
  • •remission is confirmed by at least one sigmoidoscopy
  • •Medication which affects the gastrointestinal motility or perception should be stopped at least 24 hours before the study

Exclusion Criteria

  • •For all groups:
  • •co-morbidity: severe kidney- and/or liver disease or thyroid abnormalities and impaired clotting
  • •Abdominal chirurgy (except for an uncomplicated appendectomy)

Outcomes

Primary Outcomes

differences in visceral sensitivity in different study groups (Visceral sensitivity will me measured by performing a rectal barostat test)

Time Frame: at time of investigation (rectal barostat test), Day 1

Visceral sensitivity will me measured by performing a rectal barostat test

Secondary Outcomes

  • 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 1)

Investigators

Sponsor
KU Leuven
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Guy Boeckxstaens

Prof. Dr.

KU Leuven

Study Sites (2)

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