Visceral Sensitivity in IBD (Irritable Bowel Disease) and IBS (Irritable Bowel Syndrome)
Not applicable · Testing Sample collection · 1 site · KU Leuven
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Sample collection to better understand how the disease works. Condition(s) listed: IBS, Ulcerative Colitis, Active and Ulcerative Colitis, Remission (3a: With IBS Symptoms, 3b: Without IBS Symptoms).
It is open-label: participants know what they are receiving.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 18 to 65
- Any sex
- Healthy volunteers accepted
Some of the main requirements, copied from the record:
- For group 1: IBS
- Irritable Bowel Syndrome (IBS) (ROME III criteria)
- No obvious organic explanation for the IBS symptoms
Plus 15 more requirement(s). There are also 3 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 99999999 participants are expected to take part.
- Start date: 2010-02.
- Main results expected around 2099-01 (estimate from the record).
- 1 study site listed (1 marked recruiting) in Belgium.
Main thing being measured
- differences in visceral sensitivity in different study groups (Visceral sensitivity will me measured by performing a rectal barostat test) (at time of investigation (rectal barostat test), Day 1)
In the researchers’ words
Aim: More insight in pathogenesis of IBS and IBD. Samples are collected in context of an European research project.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | IBS; Ulcerative Colitis, Active; Ulcerative Colitis, Remission (3a: With IBS Symptoms, 3b: Without IBS Symptoms); Healthy Controls; Crohn's Disease, Active; Crohn's Disease, Remission (6a: With IBS Symptoms, 6b: Without IBS Symptoms) |
| Lead sponsor | KU Leuven |
| Enrollment | 99999999 (estimated) |
| Start date | 2010-02 |
| Primary completion (est.) | 2099-01 |
| First posted | 2015-04-21 |
| Last updated | 2023-02-08 |
| Official title | Visceral Sensitivity in IBD and IBS: Role of Inflammation, Immune Activity and Genetic Factors |
| ClinicalTrials.gov ID | NCT02421705 |
Interventions
- 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
Full eligibility criteria (from the record)
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)
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospitals Leuven | Leuven, Vlaams-Brabant | Belgium | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.