Clinical trial NCT05886322: Remote Monitoring of IBD
Official title: Comparison of Patient Reported Disease Activity Scores Combined With Fecal Calprotectin Home Tests for Remote Monitoring of IBD Patients: a Multicenter Prospective Validation Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Inflammatory Bowel Diseases
Crohn Disease
Ulcerative Colitis
Keywords: fecal calprotectin
patient reported outcome measures
mucosal inflammation
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: Maastricht University
First posted: 2023-06-02
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with an established diagnosis of CD or UC, scheduled for an ileocolonoscopy or sigmoidoscopy as part of routine care at the endoscopy ward of one of the participating centers, are eligible for participation.

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.

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Eligibility criteria: 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

Primary outcomes:
measure: Prediction of mucosal inflammation in daily clinical practice with PROMs and FC home test
timeFrame: week 0 (i.e. in the week before the colonoscopy)
measure: Recalibration of PROMs
timeFrame: week 0 (i.e. in the week before the colonoscopy)
Secondary outcomes:
measure: prediction of mucosal inflammation in strict trial setting with PROMs and FC home test
timeFrame: week 0 (i.e. in the week before the colonoscopy)
measure: Agreement between FC home test and routine laboratory tests
timeFrame: week 0-1 (i.e. FC home test in the week before the colonoscopy and the laboratory test at the day of the colonoscopy)
measure: Association between clinical (abdominal pain) and histologic disease activity
timeFrame: week 0-1
measure: Association between IBD-control and histologic disease activity
timeFrame: week 0-1
Other outcomes:
Locations:
city: Den Bosch
country: Netherlands
facility: Jeroen Bosch Hospital
city: Eindhoven
country: Netherlands
facility: Catharina Hospital Eindhoven
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Centre
city: Rotterdam
country: Netherlands
facility: Franciscus Gasthuis&Vlietland
city: Sittard
country: Netherlands
facility: Zuyderland Medical Centre
Study officials:
affiliation: Maastricht University Medical Centre
name: prof. dr. Pierik
role: PRINCIPAL_INVESTIGATOR
References:
citation: de Jong MJ, Roosen D, Degens JHRJ, van den Heuvel TRA, Romberg-Camps M, Hameeteman W, Bodelier AGL, Romanko I, Lukas M, Winkens B, Markus T, Masclee AAM, van Tubergen A, Jonkers DMAE, Pierik MJ. Development and Validation of a Patient-reported Score to Screen for Mucosal Inflammation in Inflammatory Bowel Disease. J Crohns Colitis. 2019 Apr 26;13(5):555-563. doi: 10.1093/ecco-jcc/jjy196.
citation: Van Deen WK, van der Meulen-de Jong AE, Parekh NK, Kane E, Zand A, DiNicola CA, Hall L, Inserra EK, Choi JM, Ha CY, Esrailian E, van Oijen MG, Hommes DW. Development and Validation of an Inflammatory Bowel Diseases Monitoring Index for Use With Mobile Health Technologies. Clin Gastroenterol Hepatol. 2016 Dec;14(12):1742-1750.e7. doi: 10.1016/j.cgh.2015.10.035. Epub 2015 Nov 18.
citation: Bennebroek Evertsz' F, Hoeks CC, Nieuwkerk PT, Stokkers PC, Ponsioen CY, Bockting CL, Sanderman R, Sprangers MA. Development of the patient Harvey Bradshaw index and a comparison with a clinician-based Harvey Bradshaw index assessment of Crohn's disease activity. J Clin Gastroenterol. 2013 Nov-Dec;47(10):850-6. doi: 10.1097/MCG.0b013e31828b2196.
citation: Bennebroek Evertsz' F, Nieuwkerk PT, Stokkers PC, Ponsioen CY, Bockting CL, Sanderman R, Sprangers MA. The patient simple clinical colitis activity index (P-SCCAI) can detect ulcerative colitis (UC) disease activity in remission: a comparison of the P-SCCAI with clinician-based SCCAI and biological markers. J Crohns Colitis. 2013 Dec;7(11):890-900. doi: 10.1016/j.crohns.2012.11.007. Epub 2012 Dec 24.
citation: Bodger K, Ormerod C, Shackcloth D, Harrison M; IBD Control Collaborative. Development and validation of a rapid, generic measure of disease control from the patient's perspective: the IBD-control questionnaire. Gut. 2014 Jul;63(7):1092-102. doi: 10.1136/gutjnl-2013-305600. Epub 2013 Oct 9.
citation: Clara I, Lix LM, Walker JR, Graff LA, Miller N, Rogala L, Rawsthorne P, Bernstein CN. The Manitoba IBD Index: evidence for a new and simple indicator of IBD activity. Am J Gastroenterol. 2009 Jul;104(7):1754-63. doi: 10.1038/ajg.2009.197. Epub 2009 May 19.