Inflammatory Bowel Diseases, Crohn Disease, Ulcerative Colitis
Conditions
Keywords
fecal calprotectin, patient reported outcome measures, mucosal inflammation
Brief summary
Crohn's disease (CD) and ulcerative colitis (UC) are chronic inflammatory bowel diseases (IBD) with a heterogeneous disease course. Recurrent mucosal inflammation or chronic subclinical inflammation results in damage to the bowel and complications like stenosis, fistula and colorectal cancer. Therefore, tight control of mucosal inflammation is important to prevent complications. The goal of this multicenter observational cohort study is to determine the best remote monitoring tool for predicting mucosal inflammation in adult patients with inflammatory bowel disease, relative to the gold standard endoscopy. Participants will be asked to fill out questionnaires regarding disease activity (MIAH, mHI, IBD-control, Manitoba IBD Index, p-HBI/p-SCCAI), perform a FC home test and collect one stool sample for routine laboratory calprotectin measurement, before the start of the bowel preparation for the ileocolonoscopy. During this ileocolonoscopy, endoscopic disease activity will be determined. .
Interventions
DIAGNOSTIC_TESTpatient reported outcome measures
MIAH, mHI, Manotiba IBD Index, p-HBI/SCCAI, IBD-control
DIAGNOSTIC_TESTfecal calprotectin
fecal calprotectin point-of-care test and laboratory test
DIAGNOSTIC_TESTcolonoscopy
endoscopic activity scores (SES-CD, UCEIS, MES)
Sponsors
Maastricht University
Maastricht University Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Established diagnosis of CD or UC according to ECCO guidelines * CD or UC patients scheduled for an ileocolonoscopy, or UC patients scheduled for an sigmoidoscopy at the endoscopy ward of one of the participating centers (regardless of indication) * Aged 18 years or older * Smartphone with internet access (for use FC home test)
Exclusion criteria
* Unclassified IBD * Ileostomy, colostomy, ileoanal pouch anastomosis or ileorectal anastomosis * Isolated upper gastro-intestinal CD, or isolated peri-anal disease * Insufficient knowledge of Dutch language
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prediction of mucosal inflammation in daily clinical practice with PROMs and FC home test | week 0 (i.e. in the week before the colonoscopy) | — |
| Recalibration of PROMs | week 0 (i.e. in the week before the colonoscopy) | Recalibrate PROMs with the FC home test to optimise prediction of mucosal inflammation, relative to the gold standard ileocolonoscopy, for use in daily clinical practice |
Secondary
| Measure | Time frame |
|---|---|
| prediction of mucosal inflammation in strict trial setting with PROMs and FC home test | week 0 (i.e. in the week before the colonoscopy) |
| Agreement between FC home test and routine laboratory tests | week 0-1 (i.e. FC home test in the week before the colonoscopy and the laboratory test at the day of the colonoscopy) |
| Association between clinical (abdominal pain) and histologic disease activity | week 0-1 |
| Association between IBD-control and histologic disease activity | week 0-1 |
Countries
Netherlands
Contacts
Primary Contactprof. dr. Pierik
Backup ContactLM Janssen, MD
Outcome results
None listed