Comparison of patient reported disease activity scores combined with calprotectin home tests for remote monitoring of IBD patients: a cross-sectional cohort study

Crohn*s disease and ulcerative colitis are chronic inflammatory bowel diseases
(IBD) with a heterogeneous disease course. Tight control of mucosal
inflammation is important to prevent complications. With the early onset in
life and the lack of curative treatment, a lifetime of monitoring is needed.
Endoscopy is the golden standard to detect mucosal inflammation. This is
however an invasive procedure and not suitable for frequent monitoring. The
ideal monitoring test is non-invasive, simple to conduct, and detects
(imminent) disease activity, so treatment can be timely optimized. The test
should be suitable for remote monitoring and should measure both doctor*s and
patient*s perspective on disease activity. Several non-invasive patient
reported disease activity scores have been developed, such as the Monitor IBD
AT Home (MIAH) score, mobile Health Index (mHI), the Manitoba IBD Index,
IBD-control questionnaire, patient based Harvey Bradshaw Index p-HBI) and
patient based Simple Clinical Colitis Activity Score (p-SCCAI). Diagnostic
accuaracy of symptom-based monitoring is insufficient. The Maastricht
University Medical Center+ recently implemented QuantOn Cal (QOC) tests for
patients to determine fecal calprotectin at home. It is yet unknown which
patient reported score, combined with a fecal calprotectine home test, has the
best diagnostic test accuracy for mucosal inflammation. In addition, it is
hypothesized that the persistent inflammatory condition in IBD produces certain
unique volatile organic compounds (VOCs) that appear in breath and feces during
active inflammation, indicating the potential of these VOCs to serve as markers
for IBD disease monitoring. Furthermore, changes in VOCs profiles are expected
to correlate with oxylipin levels in blood.

The main objective of this study is to determine which PROM (with and without
FC home test) is best for remote monitoring mucosal inflammation in IBD
patients in daily clinical practice, relative to the gold standard
ileocolonoscopy.
Additionally, we want to redevelop and thereby optimize PROMs (with and without
FC home test) for screening for mucosal inflammation in IBD patients.

Secondary objectives:
- To determine which PROM (with and without FC home test) is best for remote
monitoring of mucosal inflammation in IBD patients in a strict trial setting,
relative to the gold standard ileocolonoscopy.
- To determine the correlation between the fecal calprotectin levels measured
by QOC home tests and by the routine laboratory tests of the participating
centers.
- To identify and validate a profile of volatile organic compounds in exhaled
breath and/or feces that predicts histological disease activity in IBD.
- To investigate the relation of oxylipins in blood to IBD mucosal
inflammation and the relation to VOCs
- To determine the association between abdominal pain and histologic disease
activity
- To determine the association between fatigue, persistent abdominal
complaints and endoscopic disease activity.
- To determine the association between anxiety and depression, persistent
abdominal complaints and endoscopic disease activity.
- The determine the association between altered quality of life, medical
consumption and work productivity in relation to persistent abdominal
complaints and endoscopic disease activity.

This is a cross-sectional cohort study. Patients are asked to fill in questions
regarding disease activity,(MIAH, mHI, Manitoba, IBD-control p-HBI/p-SCCAI) and
disease related and overall wellbeing (abdominal pain (IBD-SSS), health
consumption (MCQ), productivity and costs (PCQ), fatigue (MFI20), mental
wellbeing (VSI, PHQ-9, GAD-7) and Quality of Life (QoL) (EQ-5D-5L), perform one
calprotectin 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
according to the SES-CD or MES will be determined.
The analysis of VOCs and , oxylipins and metabolic profiles will be performed
in patients that are included at the MUMC+ only. These patients are asked to
visit the hospital one additional time to collect exhaled breath samples.
Furthermore, these patients are asked to bring an additional fecal sample
and,if patiens have IV access during endoscopy and provide consent, a blood
sample will be taken from this IV.

Participation in this study means:
- Filling out questionnaires (142 questions) online, which takes time
- Performing one or two fecal home tests by the patient self; this brings no
additional health risk
- Collecting one or two fecal sample and storing this in the fridge at home
until taken to the hospital
- If a patient from the MUMC+ agrees to participate in the additional sub-study
and thus to have their breath samples taken for the analysis of VOCs, patients
are asked to pay an additional visit to the clinic to collect the breath
samples. If these patients have IV access during the endoscopy and they
provided consent, an additional blood sample will be taken from this IV.

No potential issues of concern or additional risks are associated with
participation in this study.
Participation in this study is not associated with any direct benefit. A
possible benefit of participating in this study is the chance to play a role in
the improvement of non-invasive remote monitoring of IBD patients.
Additionally, a possible benefit is decreasing the need for endoscopic
evaluation of mucosal inflammation and thereby decreasing the risk of
complications caused by this invasive procedure. Furthermore, if patients can
be safely and accurately monitored remotely this can post a time benefit for
both patients and health care professionals. The additional questions about IBS
complaints could help to gain insight into abdominal complaints in IBD patients
whenever inflammation is not immediately detected.