Remote Monitoring of IBD

NCT05886322 | Unknown

• 2 other identifiers: NL75205.068.20NL9313
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 5

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. .

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Ulcerative Colitis

Keywords

fecal calprotectin; patient reported outcome measures; mucosal inflammation

Outcome Measures

Primary Outcomes (2)

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

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

• 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

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

Secondary Outcomes (4)

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

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

• 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)

• Association between clinical (abdominal pain) and histologic disease activity

  week 0-1

• Association between IBD-control and histologic disease activity

  week 0-1

Interventions

patient reported outcome measures DIAGNOSTIC_TEST

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

fecal calprotectin DIAGNOSTIC_TEST

fecal calprotectin point-of-care test and laboratory test

colonoscopy DIAGNOSTIC_TEST

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Maastricht University Medical Center: lead
• Maastricht University: collaborator

Study Sites (5)

Jeroen Bosch Hospital

's-Hertogenbosch, Netherlands

RECRUITING

Catharina Hospital Eindhoven

Eindhoven, Netherlands

NOT YET RECRUITING

Maastricht University Medical Centre

Maastricht, Netherlands

RECRUITING

Franciscus Gasthuis&Vlietland

Rotterdam, Netherlands

RECRUITING

Zuyderland Medical Centre

Sittard, Netherlands

NOT YET RECRUITING

Related Publications (7)

• 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.

  PMID: 30476099 BACKGROUND

• 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.

  PMID: 26598228 BACKGROUND

• 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.

  PMID: 23632348 BACKGROUND

• 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.

  PMID: 23269224 BACKGROUND

• 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.

  PMID: 24107590 BACKGROUND

• 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.

  PMID: 19455122 BACKGROUND

• 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.

  PMID: 39375184 DERIVED

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative; Mucositis

Interventions

Colonoscopy

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• prof. dr. Pierik

  Maastricht University Medical Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

prof. dr. Pierik

CONTACT

+31433874362; m.pierik@mumc.nl

LM Janssen, MD

CONTACT

laura.janssen@maastrichtuniversity.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2023
• First Posted: June 2, 2023
• Study Start: June 7, 2022
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: June 2, 2023

Record last verified: 2023-05

Locations

NL (5)