NCT05886322

Remote Monitoring of IBD

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 400 (estimated)
• Sponsor: Maastricht University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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. .

Conditions

• Inflammatory Bowel Diseases
• Crohn Disease
• Ulcerative Colitis

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2022-06-07
• Primary completion: 2024-06-01
• Completion: 2024-06-01
• First posted: 2023-06-02
• Last updated: 2023-06-02

Locations

5 sites across 1 country: Netherlands