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Search / Trial NCT02421705

Visceral Sensitivity in IBD (Irritable Bowel Disease) and IBS (Irritable Bowel Syndrome)

Launched by KU LEUVEN · Apr 20, 2015

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying how the sensitivity of the gut relates to conditions like Irritable Bowel Syndrome (IBS) and Inflammatory Bowel Disease (IBD), which includes Ulcerative Colitis and Crohn's Disease. The goal is to better understand these conditions and how they affect patients. The trial is currently looking for participants aged 6 to 74, including those with IBS, active or in remission Ulcerative Colitis, active or in remission Crohn's Disease, and healthy individuals without any stomach issues.

To be eligible for the trial, participants must meet certain criteria. For example, those with IBS should not have any clear physical cause for their symptoms, and those with Ulcerative Colitis or Crohn's Disease must have a diagnosis confirmed by a procedure called sigmoidoscopy. All participants will need to stop specific medications that affect gut movement at least 24 hours before the study. If you join the trial, you can expect to contribute to important research that may improve understanding and treatment of these conditions. Additionally, it's important to note that individuals with severe kidney or liver disease, thyroid issues, or those who have had certain surgeries are not eligible to participate.

Gender

ALL

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)

About Ku Leuven

KU Leuven, a prestigious research university located in Belgium, is renowned for its commitment to advancing medical science and improving patient care through innovative clinical trials. With a strong emphasis on interdisciplinary collaboration, KU Leuven integrates cutting-edge research with clinical practice, facilitating the development of new therapeutic strategies and medical technologies. The institution's robust infrastructure and expertise in various fields, including biotechnology, pharmacology, and public health, position it as a leader in conducting high-quality clinical research that adheres to rigorous ethical standards and regulatory requirements. Through its clinical trials, KU Leuven aims to contribute significantly to the global biomedical landscape and enhance health outcomes for diverse populations.

Locations

Leuven, Vlaams Brabant, Belgium

Patients applied

0 patients applied

Trial Officials

Guy Boeckxstaens, MD

Principal Investigator

Catholic University Leuven and Universitary Hospitals Leuven

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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