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Recruiting NCT02421705

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

No phase Interventional IBS Ulcerative Colitis, Active Ulcerative Colitis, Remission (3a: With IBS Symptoms, 3b: Without IBS Symptoms) Healthy Controls

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Sample collection.
Who it may be relevant to
Registry conditions: IBS, Ulcerative Colitis, Active, Ulcerative Colitis, Remission (3a: With IBS Symptoms, 3b: Without IBS Symptoms), Healthy Controls. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

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

Interventions

  • Other Sample collection
    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 outcome measures

  • 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]
Secondary outcome measures (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]

Eligibility criteria

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

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

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Basic science

Study locations

Belgium · 1 center
  • University Hospitals Leuven — Leuven

Identifiers

NCT: NCT02421705 · S51573

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗