Remote Monitoring of IBD

Recruiting

• Conditions: Inflammatory Bowel Diseases; Crohn Disease; Ulcerative Colitis

• Registration Number: NCT05886322
• Lead Sponsor: Maastricht University Medical Center

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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Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-07
• Study First Submitted: 2023-04-26
• Status Verified: 2023-05
• Study First Submitted QC: 2023-05-23
• Last Update Submitted: 2023-05-23
• Study First Posted: 2023-06-02
• Last Update Posted: 2023-06-02
• Primary Completion: 2024-06
• Study Completion: 2024-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Recalibration of PROMs	week 0 (i.e. in the week before the colonoscopy)	Recalibrate PROMs with the FC home test to optimise prediction of mucosal inflammation, relative to the gold standard ileocolonoscopy, for use in daily clinical practice
Prediction of mucosal inflammation in daily clinical practice with PROMs and FC home test	week 0 (i.e. in the week before the colonoscopy)

Secondary Outcome Measures

Name	Time	Method
Agreement between FC home test and routine laboratory tests	week 0-1 (i.e. FC home test in the week before the colonoscopy and the laboratory test at the day of the colonoscopy)
Association between IBD-control and histologic disease activity	week 0-1
prediction of mucosal inflammation in strict trial setting with PROMs and FC home test	week 0 (i.e. in the week before the colonoscopy)
Association between clinical (abdominal pain) and histologic disease activity	week 0-1

Trial Locations

Locations (5)

Maastricht University Medical Centre; 🇳🇱 Maastricht, Netherlands

Jeroen Bosch Hospital; 🇳🇱 Den Bosch, Netherlands

Catharina Hospital Eindhoven; 🇳🇱 Eindhoven, Netherlands

Zuyderland Medical Centre; 🇳🇱 Sittard, Netherlands

Franciscus Gasthuis&Vlietland; 🇳🇱 Rotterdam, Netherlands