MedTrace Logo

Remote Monitoring of IBD

NCT05886322 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 400

Last updated 2023-06-02

No results posted yet for this study

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

Interventions

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)

Sponsors & Collaborators

  • Maastricht University

    collaborator OTHER

  • Maastricht University Medical Center

    lead OTHER

Principal Investigators

  • prof. dr. Pierik · Maastricht University Medical Centre

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-07
Primary Completion
2024-06-30
Completion
2024-06-30

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05886322 on ClinicalTrials.gov