Understanding visceral sensitivity in IBS and IBD

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to gain insights into the pathogenesis of Irritable Bowel Syndrome (IBS) and Inflammatory Bowel Disease (IBD) by collecting various biological samples from participants. The methodology includes obtaining biopsies from the rectum and colon, blood samples, nasal mucosa samples, fecal samples, and conducting questionnaires. Additionally, the study will measure rectal sensitivity and colon transit, as well as perform MR scans of the brain to assess visceral sensitivity. Participants will include individuals with IBS, active ulcerative colitis, ulcerative colitis in remission, and healthy controls.

Why it matters

Who can join: the full rules

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)

Where it's running

• University Hospitals Leuven
  Leuven, Vlaams-Brabant, Belgium Recruiting

Study contacts

• Principal investigator: Guy Boeckxstaens, MD — Catholic University Leuven and Universitary Hospitals Leuven
• Study coordinator: Koen Bellens, MSc
• Email: koen.bellens@kuleuven.be
• Phone: 0032-16-341943

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.