Remote Monitoring of IBD

May 23, 2023 updated by: Maastricht University Medical Center

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

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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Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Netherlands
      • Den Bosch, Netherlands
        • Recruiting
        • Jeroen Bosch Hospital
        • Contact:
          • TEH Romkens
        • Principal Investigator:
          • TEH Romkens
      • Eindhoven, Netherlands
        • Not yet recruiting
        • Catharina Hospital Eindhoven
        • Contact:
          • LPL Gilissen
        • Principal Investigator:
          • LPL Gilissen
      • Maastricht, Netherlands
        • Recruiting
        • Maastricht University Medical Centre
        • Contact:
          • LM Janssen
          • Phone Number: +31433884190
        • Principal Investigator:
          • prof dr Pierik
      • Rotterdam, Netherlands
        • Recruiting
        • Franciscus Gasthuis&Vlietland
        • Contact:
          • RL West
        • Principal Investigator:
          • RL West
      • Sittard, Netherlands
        • Not yet recruiting
        • Zuyderland Medical Centre
        • Contact:
          • MJL Romberg-Camps
        • Principal Investigator:
          • MJL Romber-Camps

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patients with an established diagnosis of CD or UC, scheduled for an ileocolonoscopy or sigmoidoscopy as part of routine care at the endoscopy ward of one of the participating centers, are eligible for participation.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prediction of mucosal inflammation in daily clinical practice with PROMs and FC home test
Time Frame: week 0 (i.e. in the week before the colonoscopy)
week 0 (i.e. in the week before the colonoscopy)
Recalibration of PROMs
Time Frame: 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
week 0 (i.e. in the week before the colonoscopy)

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maastricht University Medical Center

Collaborators

Maastricht University

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 7, 2022

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

April 26, 2023

First Submitted That Met QC Criteria

May 23, 2023

First Posted (Estimated)

June 2, 2023

Study Record Updates

Last Update Posted (Estimated)

June 2, 2023

Last Update Submitted That Met QC Criteria

May 23, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL75205.068.20
  • NL9313 (Registry Identifier: Netherlands Trial Register)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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