NCT02421705

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
99,999,999

participants targeted

Target at P75+ for not_applicable

Timeline
885mo left

Started Feb 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress18%
Feb 2010Jan 2099

Study Start

First participant enrolled

February 1, 2010

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

July 31, 2013

Completed
1.7 years until next milestone

First Posted

Study publicly available on registry

April 21, 2015

Completed
83.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2099

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2099

Last Updated

February 8, 2023

Status Verified

February 1, 2023

Enrollment Period

89 years

First QC Date

July 31, 2013

Last Update Submit

February 7, 2023

Conditions

IBSUlcerative Colitis, ActiveUlcerative Colitis, Remission (3a: With IBS Symptoms, 3b: Without IBS Symptoms)Healthy ControlsCrohn's Disease, ActiveCrohn's Disease, Remission (6a: With IBS Symptoms, 6b: Without IBS Symptoms)

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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

Study Arms (1)

Sample collection

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

Other: Sample collection

Interventions

Sample collectionOTHER

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

Sample collection

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 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)
  • 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) 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)
  • +3 more criteria

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

RECRUITING

MeSH Terms

Conditions

Colitis, UlcerativeMotor ActivityCrohn Disease

Interventions

Specimen Handling

Condition Hierarchy (Ancestors)

ColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesInflammatory Bowel DiseasesColonic DiseasesIntestinal DiseasesBehavior

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • Guy Boeckxstaens, MD

    Catholic University Leuven and Universitary Hospitals Leuven

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Koen Bellens, MSc

CONTACT

0032-16-341943koen.bellens@kuleuven.be

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

July 31, 2013

First Posted

April 21, 2015

Study Start

February 1, 2010

Primary Completion (Estimated)

January 1, 2099

Study Completion (Estimated)

January 1, 2099

Last Updated

February 8, 2023

Record last verified: 2023-02

Locations

BE(1)