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NCT Number: NCT02421705

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

Aim:

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

Recruiting

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Key information

Conditions

IBS Behavior Colitis Colitis, Ulcerative Colonic Diseases Crohn Disease Crohn's Disease, Active Crohn's Disease, Remission (6a: With IBS Symptoms, 6b: Without IBS Symptoms) Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Healthy Controls Inflammatory Bowel Diseases Intestinal Diseases Motor Activity Ulcerative Colitis, Active Ulcerative Colitis, Remission (3a: With IBS Symptoms, 3b: Without IBS Symptoms)

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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)

  • 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

Exclusion criteria

For all groups:

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

Treatment and study plan

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

Primary outcomes

  1. differences in visceral sensitivity in different study groups (Visceral sensitivity will me measured by performing a rectal barostat test)

    Time frame: at time of investigation (rectal barostat test), Day 1

    Visceral sensitivity will me measured by performing a rectal barostat test

Secondary outcomes

  1. immune activity (measuring release of mest cell mediators in rectal biopsies, measuring parameters of immune activity in blood)

    Time frame: at time of investigation (rectal biopsy), Day 1

    measuring release of mest cell mediators in rectal biopsies, measuring parameters of immune activity in blood (for example by stimulating Peripheral Blood Mononuclear Cells)

Study contacts

Contact information is provided by the study sponsor or research team.

Koen Bellens, MSc

CONTACT

[email protected]

0032-16-341943

Sponsors and collaborators

Lead sponsor

KU Leuven

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2099
Study completion
2099
First posted
Apr 21, 2015
Registry last updated
Feb 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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