AzTrials
AzTrials

Inflammatory Bowel DiseasesNCT05886322

Remote Monitoring of IBD

An observational study of Inflammatory Bowel Diseases and Crohn Disease, run by Maastricht University Medical Center at 5 sites in Netherlands.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
patient reported outcome measures, fecal calprotectin and colonoscopy
How many people
400 participants
Where
5 sitesNetherlands
Study dates
7 Jun 2022to Jun 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

5 sites in 1 country.

prof. dr. Pierik contact

+31433874362

m.pierik@mumc.nl

LM Janssen, MD contact

laura.janssen@maastrichtuniversity.nl

5 sites in 1 country

Netherlands5 sites, 5 recruiting

  • Jeroen Bosch Hospital

    's-Hertogenbosch

    TEH Romkens

    TEH Romkens

    Recruiting

  • Catharina Hospital Eindhoven

    Eindhoven

    LPL Gilissen

    LPL Gilissen

    Not yet recruiting

  • Maastricht University Medical Centre

    Maastricht

    LM Janssen, +31433884190

    prof dr Pierik

    Recruiting

  • Franciscus Gasthuis&Vlietland

    Rotterdam

    RL West

    RL West

    Recruiting

  • Zuyderland Medical Centre

    Sittard

    MJL Romberg-Camps

    MJL Romber-Camps

    Not yet recruiting

Other trials in Netherlands

About this study

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

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.

Read more

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.

.

Being tested
patient reported outcome measures, fecal calprotectin, colonoscopy
Keywords
fecal calprotectin, patient reported outcome measures, mucosal inflammation
Medical subject headings
Inflammatory Bowel Diseases, Crohn Disease, Colitis, Ulcerative, Mucositis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • patient reported outcome measuresDiagnostic test

    MIAH, mHI, Manotiba IBD Index, p-HBI/SCCAI, IBD-control

  • fecal calprotectinDiagnostic test

    fecal calprotectin point-of-care test and laboratory test

  • colonoscopyDiagnostic test

    endoscopic activity scores (SES-CD, UCEIS, MES)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Prediction of mucosal inflammation in daily clinical practice with PROMs and FC home test

    Measured: week 0 (i.e. in the week before the colonoscopy)

  2. Recalibration of PROMs

    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

    Measured: week 0 (i.e. in the week before the colonoscopy)

Secondary outcomes (4)

  1. prediction of mucosal inflammation in strict trial setting with PROMs and FC home test

    Measured: week 0 (i.e. in the week before the colonoscopy)

  2. Agreement between FC home test and routine laboratory tests

    Measured: 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

    Measured: week 0-1

  4. Association between IBD-control and histologic disease activity

    Measured: week 0-1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jun 2023
  2. Study start7 Jun 2022
  3. Primary completionJun 2024 (estimated)
  4. Study completionJun 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05886322
Sponsor's protocol ID
NL75205.068.20
Other IDs
NL9313
Status last verified
May 2023
First submitted
26 Apr 2023
Last updated
2 Jun 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • de Jong MJ, Roosen D, Degens JHRJ, van den Heuvel TRA, Romberg-Camps M, Hameeteman W, Bodelier AGL, Romanko I, Lukas M, Winkens B, Markus T, Masclee AAM, van Tubergen A, Jonkers DMAE, Pierik MJ. Development and Validation of a Patient-reported Score to Screen for Mucosal Inflammation in Inflammatory Bowel Disease. J Crohns Colitis. 2019 Apr 26;13(5):555-563. doi: 10.1093/ecco-jcc/jjy196.

    PubMed 30476099

  • Van Deen WK, van der Meulen-de Jong AE, Parekh NK, Kane E, Zand A, DiNicola CA, Hall L, Inserra EK, Choi JM, Ha CY, Esrailian E, van Oijen MG, Hommes DW. Development and Validation of an Inflammatory Bowel Diseases Monitoring Index for Use With Mobile Health Technologies. Clin Gastroenterol Hepatol. 2016 Dec;14(12):1742-1750.e7. doi: 10.1016/j.cgh.2015.10.035. Epub 2015 Nov 18.

    PubMed 26598228

  • Bennebroek Evertsz' F, Hoeks CC, Nieuwkerk PT, Stokkers PC, Ponsioen CY, Bockting CL, Sanderman R, Sprangers MA. Development of the patient Harvey Bradshaw index and a comparison with a clinician-based Harvey Bradshaw index assessment of Crohn's disease activity. J Clin Gastroenterol. 2013 Nov-Dec;47(10):850-6. doi: 10.1097/MCG.0b013e31828b2196.

    PubMed 23632348

  • Bennebroek Evertsz' F, Nieuwkerk PT, Stokkers PC, Ponsioen CY, Bockting CL, Sanderman R, Sprangers MA. The patient simple clinical colitis activity index (P-SCCAI) can detect ulcerative colitis (UC) disease activity in remission: a comparison of the P-SCCAI with clinician-based SCCAI and biological markers. J Crohns Colitis. 2013 Dec;7(11):890-900. doi: 10.1016/j.crohns.2012.11.007. Epub 2012 Dec 24.

    PubMed 23269224

  • Bodger K, Ormerod C, Shackcloth D, Harrison M; IBD Control Collaborative. Development and validation of a rapid, generic measure of disease control from the patient's perspective: the IBD-control questionnaire. Gut. 2014 Jul;63(7):1092-102. doi: 10.1136/gutjnl-2013-305600. Epub 2013 Oct 9.

    PubMed 24107590

  • Clara I, Lix LM, Walker JR, Graff LA, Miller N, Rogala L, Rawsthorne P, Bernstein CN. The Manitoba IBD Index: evidence for a new and simple indicator of IBD activity. Am J Gastroenterol. 2009 Jul;104(7):1754-63. doi: 10.1038/ajg.2009.197. Epub 2009 May 19.

    PubMed 19455122

  • Janssen L, van Linschoten RCA, West RL, Gilissen LPL, Romberg-Camps M, Brandts L, Mujagic Z, Romkens TE, Pierik M. Predicting mucosal inflammation in IBD patients using patient-reported symptom scores and a faecal calprotectin home test: protocol for a multicentre prospective validation study. BMJ Open. 2024 Oct 7;14(10):e076290. doi: 10.1136/bmjopen-2023-076290.

    PubMed 39375184

Questions about this trial

What is this clinical trial studying?

An observational study of Inflammatory Bowel Diseases and Crohn Disease, run by Maastricht University Medical Center at 5 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 2 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact prof. dr. Pierik (+31433874362, m.pierik@mumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05886322, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2023.

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