Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
400 participants
OBSERVATIONAL
2022-06-07
2024-06-30
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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patient reported outcome measures
MIAH, mHI, Manotiba IBD Index, p-HBI/SCCAI, IBD-control
fecal calprotectin
fecal calprotectin point-of-care test and laboratory test
colonoscopy
endoscopic activity scores (SES-CD, UCEIS, MES)
Eligibility Criteria
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Inclusion Criteria
* 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
* Ileostomy, colostomy, ileoanal pouch anastomosis or ileorectal anastomosis
* Isolated upper gastro-intestinal CD, or isolated peri-anal disease
* Insufficient knowledge of Dutch language
18 Years
ALL
No
Sponsors
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Maastricht University
OTHER
Maastricht University Medical Center
OTHER
Responsible Party
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Principal Investigators
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prof. dr. Pierik
Role: PRINCIPAL_INVESTIGATOR
Maastricht University Medical Centre
Locations
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Jeroen Bosch Hospital
's-Hertogenbosch, , Netherlands
Catharina Hospital Eindhoven
Eindhoven, , Netherlands
Maastricht University Medical Centre
Maastricht, , Netherlands
Franciscus Gasthuis&Vlietland
Rotterdam, , Netherlands
Zuyderland Medical Centre
Sittard, , Netherlands
Countries
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Central Contacts
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Facility Contacts
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TEH Romkens
Role: primary
LPL Gilissen
Role: primary
LM Janssen
Role: primary
RL West
Role: primary
MJL Romberg-Camps
Role: primary
References
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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.
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.
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.
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.
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.
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.
Janssen L, van Linschoten RCA, West RL, Gilissen LPL, Romberg-Camps M, Brandts L, Mujagic Z, Romkens TE, Pierik M. Predicting mucosal inflammation in IBD patients using patient-reported symptom scores and a faecal calprotectin home test: protocol for a multicentre prospective validation study. BMJ Open. 2024 Oct 7;14(10):e076290. doi: 10.1136/bmjopen-2023-076290.
Other Identifiers
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NL9313
Identifier Type: REGISTRY
Identifier Source: secondary_id
NL75205.068.20
Identifier Type: -
Identifier Source: org_study_id
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