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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
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. .
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
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
Start Date
June 7, 2022
Primary Completion Date
June 1, 2024
Completion Date
June 1, 2024
Last Updated
June 2, 2023
400
ESTIMATED participants
patient reported outcome measures
DIAGNOSTIC_TEST
fecal calprotectin
DIAGNOSTIC_TEST
colonoscopy
DIAGNOSTIC_TEST
Lead Sponsor
Maastricht University Medical Center
Collaborators
NCT06226883
NCT07271069
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT06975722