Remote Monitoring of IBD

Maastricht University Medical Centre (MUMC)

Status: Enrolling

Conditions: Ulcerative Colitis; Inflammatory Bowel Diseases; Crohn Disease

Treatments: Diagnostic Test: patient reported outcome measures; Diagnostic Test: colonoscopy; Diagnostic Test: fecal calprotectin

Study type: Observational

Funder types: Other

Identifiers

NCT05886322

NL75205.068.20

NL9313 (Registry Identifier)

Details and patient eligibility

About

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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Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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