Remote Monitoring of IBD

Study Overview
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Brief Summary
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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. .

Official Title
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Comparison of Patient Reported Disease Activity Scores Combined With Fecal Calprotectin Home Tests for Remote Monitoring of IBD Patients: a Multicenter Prospective Validation Study

Conditions
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Inflammatory Bowel Diseases, Crohn Disease, Ulcerative Colitis

Intervention / Treatment
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* Diagnostic Test: patient reported outcome measures
* Diagnostic Test: fecal calprotectin
* Diagnostic Test: colonoscopy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: patient reported outcome measures|MIAH, mHI, Manotiba IBD Index, p-HBI/SCCAI, IBD-control|
|Diagnostic Test: fecal calprotectin|fecal calprotectin point-of-care test and laboratory test|
|Diagnostic Test: colonoscopy|endoscopic activity scores (SES-CD, UCEIS, MES)|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | week 0 (i.e. in the week before the colonoscopy) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fecal calprotectin, patient reported outcome measures, mucosal inflammation