Understanding visceral sensitivity in IBS and IBD

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

This study is trying to understand how the body reacts to gut sensations in people with Irritable Bowel Syndrome, active and inactive Inflammatory Bowel Disease, and healthy individuals by collecting samples and measuring different body responses.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 99999999 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: KU Leuven (Academic / other)
• Locations: 1 site (Leuven, Vlaams-Brabant)
• Trial ID: NCT02421705 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include individuals diagnosed with IBS, active ulcerative colitis, ulcerative colitis in remission, or healthy individuals without abdominal complaints.

Not a fit: Patients with obvious organic explanations for their gastrointestinal symptoms or those currently on medications affecting gastrointestinal motility may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance understanding of IBS and IBD, potentially leading to improved treatments for these conditions.

How similar studies have performed: While there have been studies on IBS and IBD, this specific approach involving comprehensive sample collection and multiple assessments is relatively novel.

Eligibility criteria

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 this trial is running

Leuven, Vlaams-Brabant

• 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

Conditions IBS; Ulcerative Colitis, Active; Ulcerative Colitis, Remission; Healthy Controls; Crohn's Disease, Active; Crohn's Disease, Remission