Remote Monitoring of IBD

Maastricht University Medical Center (Other)
Overall Status
Recruiting ID
Maastricht University (Other)

Study Details

Study Description

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.


Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: patient reported outcome measures
  • Diagnostic Test: fecal calprotectin
  • Diagnostic Test: colonoscopy

Study Design

Study Type:
Anticipated Enrollment :
400 participants
Observational Model:
Time Perspective:
Official Title:
Comparison of Patient Reported Disease Activity Scores Combined With Fecal Calprotectin Home Tests for Remote Monitoring of IBD Patients: a Multicenter Prospective Validation Study
Actual Study Start Date :
Jun 7, 2022
Anticipated Primary Completion Date :
Jun 1, 2024
Anticipated Study Completion Date :
Jun 1, 2024

Outcome Measures

Primary Outcome Measures

  1. Prediction of mucosal inflammation in daily clinical practice with PROMs and FC home test [week 0 (i.e. in the week before the colonoscopy)]

  2. 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

Secondary Outcome Measures

  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)]

  2. 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)]

  3. Association between clinical (abdominal pain) and histologic disease activity [week 0-1]

  4. Association between IBD-control and histologic disease activity [week 0-1]

Eligibility Criteria


Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Accepts 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

Contacts and Locations


Site City State Country Postal Code
1 Jeroen Bosch Hospital Den Bosch Netherlands
2 Catharina Hospital Eindhoven Eindhoven Netherlands
3 Maastricht University Medical Centre Maastricht Netherlands
4 Franciscus Gasthuis&Vlietland Rotterdam Netherlands
5 Zuyderland Medical Centre Sittard Netherlands

Sponsors and Collaborators

  • Maastricht University Medical Center
  • Maastricht University


  • Principal Investigator: prof. dr. Pierik, Maastricht University Medical Centre

Study Documents (Full-Text)

None provided.

More Information


Responsible Party:
Maastricht University Medical Center Identifier:
Other Study ID Numbers:
  • NL75205.068.20
  • NL9313
First Posted:
Jun 2, 2023
Last Update Posted:
Jun 2, 2023
Last Verified:
May 1, 2023
Studies a U.S. FDA-regulated Drug Product:
Studies a U.S. FDA-regulated Device Product:
Keywords provided by Maastricht University Medical Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 2, 2023