Remote Monitoring of IBD

Ulcerative Colitis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05886322
• Other study ID #: NL75205.068.20
• Secondary ID: NL9313
• Status: Recruiting
• Start date: June 7, 2022
• Est. completion date: June 2024

Study information

• Verified date: May 2023
• Source: Maastricht University Medical Center
• Contact: prof. dr. Pierik
• Phone: +31433874362
• Email: m.pierik[@]mumc.nl
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Crohn Disease
• Inflammatory Bowel Diseases
• Ulcerative Colitis

Intervention

Diagnostic Test:
• patient reported outcome measures
MIAH, mHI, Manotiba IBD Index, p-HBI/SCCAI, IBD-control
• fecal calprotectin
fecal calprotectin point-of-care test and laboratory test
• colonoscopy
endoscopic activity scores (SES-CD, UCEIS, MES)

Locations

Country	Name	City	State
Netherlands	Jeroen Bosch Hospital	Den Bosch
Netherlands	Catharina Hospital Eindhoven	Eindhoven
Netherlands	Maastricht University Medical Centre	Maastricht
Netherlands	Franciscus Gasthuis&Vlietland	Rotterdam
Netherlands	Zuyderland Medical Centre	Sittard

Sponsors (2)

Lead Sponsor	Collaborator
Maastricht University Medical Center	Maastricht University

Country where clinical trial is conducted

Netherlands, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prediction of mucosal inflammation in daily clinical practice with PROMs and FC home test		week 0 (i.e. in the week before the colonoscopy)
Primary	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	prediction of mucosal inflammation in strict trial setting with PROMs and FC home test		week 0 (i.e. in the week before the colonoscopy)
Secondary	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)
Secondary	Association between clinical (abdominal pain) and histologic disease activity		week 0-1
Secondary	Association between IBD-control and histologic disease activity		week 0-1