IBSNCT02421705
Visceral Sensitivity in IBD (Irritable Bowel Disease) and IBS (Irritable Bowel Syndrome)
A study testing Sample collection in people with IBS and Ulcerative Colitis, Active, run by KU Leuven at 1 site in Belgium.
Trial summary
Aim: More insight in pathogenesis of IBS and IBD. Samples are collected in context of an European research project. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- IBS, Ulcerative Colitis, Active, Ulcerative Colitis, Remission (3a: With IBS Symptoms, 3b: Without IBS Symptoms)
- What is being tested?
- Sample collection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99,999,999 participants
- Where
- 1 siteBelgium
- Study dates
- 12 Mar 2010to Jan 2099
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
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- 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
- 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)
- 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
Who cannot join
- For all groups:
- co-morbidity: severe kidney- and/or liver disease or thyroid abnormalities and impaired clotting
- Abdominal chirurgy (except for an uncomplicated appendectomy)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
University Hospitals Leuven
Leuven, Vlaams-Brabant, 3000
Lien Beullens, MSc, 0032-16-341943, lien.beullens@kuleuven.be
Dafne Balemans, MSc, 0032-16-330158, dafne.balemans@med.kuleuven.be
About this study
Official title: Visceral Sensitivity in IBD and IBS: Role of Inflammation, Immune Activity and Genetic Factors
Aim:
More insight in pathogenesis of IBS and IBD. Samples are collected in context of an European research project.
Read the 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
- Conditions
- 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)
- Being tested
- Sample collection
- Medical subject headings
- Colitis, Ulcerative, Motor Activity, Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Sample collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
measuring release of mest cell mediators in rectal biopsies, measuring parameters of immune activity in blood (for example by stimulating Peripheral Blood Mononuclear Cells)
Measured: at time of investigation (rectal biopsy), Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2015 (estimated)
- Study start12 Mar 2010
- Primary completionJan 2099 (estimated)
- Study completionJan 2099 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IBSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 99,999,999 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guy Boeckxstaens, KU Leuven
- Investigators
- Guy Boeckxstaens, MD, Principal investigator, Catholic University Leuven and Universitary Hospitals Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02421705
- Sponsor's protocol ID
- S51573
- Status last verified
- Oct 2026
- First submitted
- 31 Jul 2013
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No