Multiple Digital Biomarkers for Optimization of IBD Care

NCT07159776 | Not Yet Recruiting

• 1 other identifier: imelda 202501
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

To develop digital biomarkers associated with disease activity of inflammatory bowel disease

Conditions

Crohn Disease (CD); Ulcerative Colitis (UC); Inflammatory Bowel Disease (IBD)

Keywords

biomarkers; artificial intelligence; wearable; shopping data; life style

Outcome Measures

Primary Outcomes (1)

• Proportion of patients in which a flare can be detected based on passive monitoring data.

  1 year

Secondary Outcomes (5)

• Proportion of patients in which a biomarker flare can be detected based on passive monitoring data

  1 year

• Proportion of patients in which an objective disease flare (combination of flare and biomarker flare) can be detected based on passive monitoring

  1 year

• Proportion of patients in which a flare can be detected based on food purchase data

  1 year

• Proportion of patients in which a biomarker flare can be detected based on food purchase data

  1 year

• Proportion of patients in which an objective disease flare (combination of flare and biomarker flare) can be detected based on food purchase data

  1 year

Other Outcomes (5)

• - Interval between onset of a flare and detection based on passive monitoring data

  1 year

• - Subgroup analysis based on the food frequency questionnaire

  1 year

• - Patient satisfaction based on patient experience questionnaire

  1 year

Study Arms (1)

Patients with IBD

1. Patients with IBD in longstanding remission (\>2 years) (maximum of 20 patients) 2. Patients with IBD recent event (diagnosis or flare of IBD) (\<1year) (minimum 20 patients) 3. Additional patients with IBD in standard follow up.

Device: monitoring of wearable data, shopping data, biomarkers and patient reported outcomes

Interventions

monitoring of wearable data, shopping data, biomarkers and patient reported outcomes DEVICE

1. All participants will receive a wearable device type Corsano Health Cardio watch 287-2 which is provided by the sponsor via Inovigate. Participants will be encouraged to wear the device 24h per day and need to wear the wearable device at least 12 hours per day, preferential during daytime. 2. All participants will receive a loyalty card (Xtra card Colruyt group) which is provided by the sponsor via Inovigate for food data capturing. The patient is requested to execute all grocery shopping at one of the Colruyt Group stores. He/she will always need to offer the loyalty card to the cashier prior to payment. The purchase receipt will then be automatically sent to the central food data repository at the sponsor set up for this study. Non-food or non-food related data will neither be captured nor stored during the trial. 3. biomarkers in blood and feaces will be monitored according to standard of care 4. patient reported outcomes will be monitored according to standard of care

Patients with IBD

Eligibility Criteria

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

Study Population

This is an open label observational trial with partially blinded data collection (wearable and shopping data blinded for the patient and treating HCP). Patients in the study will not be randomized. Patients will be recruited via planned outpatient visits and day clinic admissions. Patients will be allocated to one of the three target patient groups at the investigator's discretion. 1. Patients with IBD in longstanding remission (\>2 years) (maximum of 20 patients) 2. Patients with IBD recent event (diagnosis or flare of IBD) (\<1year) (minimum 20 patients) 3. Additional patients with IBD in standard follow up. From the moment 60 patients are included, no additional patients can be recruited in group 1 or 3 prior to completion of group 2.

You may qualify if:

• Males or females aged \> 18 years
• Diagnosis of CD, UC or IBD-unspecified for at least 1 month
• Treatment with conventional or advanced therapy for IBD at initiation of the study
• The patient must have access to an email address
• The patient must be willing to perform all the groceries shopping at any of the Colruyt Group stores during this study, using an Xtra card created by the study team.
• Capacity to independently answer regular digital questionnaires
• Capacity and willingness to use a smartphone and activity tracker

You may not qualify if:

• Planned extended (\> 1 month) overseas travel during the study period of 12 months, if internet access would be impossible, inconvenient or unaffordable during this time
• Previous colectomy
• Inability to communicate well with investigators or unable to comply with the study requirements
• Significant medical condition interfering with physiological measurements trough a wearable device (heart failure, pacemaker or defibrillator)

Sponsors & Collaborators

• Imelda GI Clinical Research Center: lead
• Agentschap Innoveren & Ondernemen (VLAIO): collaborator

Study Sites (1)

Imelda General Hospital

Bonheiden, 2820, Belgium

Location

Related Publications (16)

• Hirten RP, Danieletto M, Sanchez-Mayor M, Whang JK, Lee KW, Landell K, Zweig M, Helmus D, Fuchs TJ, Fayad ZA, Nadkarni GN, Keefer L, Suarez-Farinas M, Sands BE. Physiological Data Collected From Wearable Devices Identify and Predict Inflammatory Bowel Disease Flares. Gastroenterology. 2025 May;168(5):939-951.e5. doi: 10.1053/j.gastro.2024.12.024. Epub 2025 Jan 16.

  PMID: 39826619 BACKGROUND

• Ghosh S, Louis E, Beaugerie L, Bossuyt P, Bouguen G, Bourreille A, Ferrante M, Franchimont D, Frost K, Hebuterne X, Marshall JK, O'Shea C, Rosenfeld G, Williams C, Peyrin-Biroulet L. Development of the IBD Disk: A Visual Self-administered Tool for Assessing Disability in Inflammatory Bowel Diseases. Inflamm Bowel Dis. 2017 Mar;23(3):333-340. doi: 10.1097/MIB.0000000000001033.

  PMID: 28146002 BACKGROUND

• Rowan C, Hirten R. The future of telemedicine and wearable technology in IBD. Curr Opin Gastroenterol. 2022 Jul 1;38(4):373-381. doi: 10.1097/MOG.0000000000000845.

  PMID: 35762696 BACKGROUND

• Singh B, Chastin S, Miatke A, Curtis R, Dumuid D, Brinsley J, Ferguson T, Szeto K, Simpson C, Eglitis E, Willems I, Maher C. Real-World Accuracy of Wearable Activity Trackers for Detecting Medical Conditions: Systematic Review and Meta-Analysis. JMIR Mhealth Uhealth. 2024 Aug 30;12:e56972. doi: 10.2196/56972.

  PMID: 39213525 BACKGROUND

• Louis S, Lembrechts N, Pouillon L. Towards a Greener IBD-Care: Let's INTERACT! United European Gastroenterol J. 2025 Mar;13(2):276-277. doi: 10.1002/ueg2.12728. Epub 2024 Dec 4. No abstract available.

  PMID: 39632541 BACKGROUND

• Pouillon L, Hoefkens E, Verheyen V, Bronswijk M, Van Olmen A, Van Dessel S, Siborgs N, Bossuyt P. Letter to the Editor: Feasibility and Efficiency of an E-Health Preadmission Assessment System for Intravenous Therapy in Inflammatory Bowel Disease. Inflamm Bowel Dis. 2020 Jan 6;26(2):e11-e12. doi: 10.1093/ibd/izz304. No abstract available.

  PMID: 31793628 BACKGROUND

• Bossuyt P, Hoefkens E, Pouillon L. Prime Time Was Yesterday for Patient-reported Outcomes in Daily Care of Patients With Inflammatory Bowel Diseases. Clin Gastroenterol Hepatol. 2018 Nov;16(11):1839. doi: 10.1016/j.cgh.2018.05.029. No abstract available.

  PMID: 30343866 BACKGROUND

• Schoenfeld R, Nguyen GC, Bernstein CN. Integrated Care Models: Optimizing Adult Ambulatory Care in Inflammatory Bowel Disease. J Can Assoc Gastroenterol. 2018 Oct 15;3(1):44-53. doi: 10.1093/jcag/gwy060. eCollection 2020 Feb.

  PMID: 34169226 BACKGROUND

• Turner D, Ricciuto A, Lewis A, D'Amico F, Dhaliwal J, Griffiths AM, Bettenworth D, Sandborn WJ, Sands BE, Reinisch W, Scholmerich J, Bemelman W, Danese S, Mary JY, Rubin D, Colombel JF, Peyrin-Biroulet L, Dotan I, Abreu MT, Dignass A; International Organization for the Study of IBD. STRIDE-II: An Update on the Selecting Therapeutic Targets in Inflammatory Bowel Disease (STRIDE) Initiative of the International Organization for the Study of IBD (IOIBD): Determining Therapeutic Goals for Treat-to-Target strategies in IBD. Gastroenterology. 2021 Apr;160(5):1570-1583. doi: 10.1053/j.gastro.2020.12.031. Epub 2021 Feb 19.

  PMID: 33359090 BACKGROUND

• Magro F, Gionchetti P, Eliakim R, Ardizzone S, Armuzzi A, Barreiro-de Acosta M, Burisch J, Gecse KB, Hart AL, Hindryckx P, Langner C, Limdi JK, Pellino G, Zagorowicz E, Raine T, Harbord M, Rieder F; European Crohn's and Colitis Organisation [ECCO]. Third European Evidence-based Consensus on Diagnosis and Management of Ulcerative Colitis. Part 1: Definitions, Diagnosis, Extra-intestinal Manifestations, Pregnancy, Cancer Surveillance, Surgery, and Ileo-anal Pouch Disorders. J Crohns Colitis. 2017 Jun 1;11(6):649-670. doi: 10.1093/ecco-jcc/jjx008. No abstract available.

  PMID: 28158501 BACKGROUND

• Harbord M, Eliakim R, Bettenworth D, Karmiris K, Katsanos K, Kopylov U, Kucharzik T, Molnar T, Raine T, Sebastian S, de Sousa HT, Dignass A, Carbonnel F; European Crohn's and Colitis Organisation [ECCO]. Third European Evidence-based Consensus on Diagnosis and Management of Ulcerative Colitis. Part 2: Current Management. J Crohns Colitis. 2017 Jul 1;11(7):769-784. doi: 10.1093/ecco-jcc/jjx009. No abstract available.

  PMID: 28513805 BACKGROUND

• Adamina M, Minozzi S, Warusavitarne J, Buskens CJ, Chaparro M, Verstockt B, Kopylov U, Yanai H, Vavricka SR, Sigall-Boneh R, Sica GS, Reenaers C, Peros G, Papamichael K, Noor N, Moran GW, Maaser C, Luglio G, Kotze PG, Kobayashi T, Karmiris K, Kapizioni C, Iqbal N, Iacucci M, Holubar S, Hanzel J, Sabino JG, Gisbert JP, Fiorino G, Fidalgo C, Ellu P, El-Hussuna A, de Groof J, Czuber-Dochan W, Casanova MJ, Burisch J, Brown SR, Bislenghi G, Bettenworth D, Battat R, Atreya R, Allocca M, Agrawal M, Raine T, Gordon H, Myrelid P. ECCO Guidelines on Therapeutics in Crohn's Disease: Surgical Treatment. J Crohns Colitis. 2024 Oct 15;18(10):1556-1582. doi: 10.1093/ecco-jcc/jjae089.

  PMID: 38878002 BACKGROUND

• Burisch J, Zhao M, Odes S, De Cruz P, Vermeire S, Bernstein CN, Kaplan GG, Duricova D, Greenberg D, Melberg HO, Watanabe M, Ahn HS, Targownik L, Pittet VEH, Annese V, Park KT, Katsanos KH, Hoivik ML, Krznaric Z, Chaparro M, Loftus EV Jr, Lakatos PL, Gisbert JP, Bemelman W, Moum B, Gearry RB, Kappelman MD, Hart A, Pierik MJ, Andrews JM, Ng SC, D'Inca R, Munkholm P. The cost of inflammatory bowel disease in high-income settings: a Lancet Gastroenterology & Hepatology Commission. Lancet Gastroenterol Hepatol. 2023 May;8(5):458-492. doi: 10.1016/S2468-1253(23)00003-1. Epub 2023 Mar 2.

  PMID: 36871566 BACKGROUND

• Ng SC, Shi HY, Hamidi N, Underwood FE, Tang W, Benchimol EI, Panaccione R, Ghosh S, Wu JCY, Chan FKL, Sung JJY, Kaplan GG. Worldwide incidence and prevalence of inflammatory bowel disease in the 21st century: a systematic review of population-based studies. Lancet. 2017 Dec 23;390(10114):2769-2778. doi: 10.1016/S0140-6736(17)32448-0. Epub 2017 Oct 16.

  PMID: 29050646 BACKGROUND

• Ungaro R, Mehandru S, Allen PB, Peyrin-Biroulet L, Colombel JF. Ulcerative colitis. Lancet. 2017 Apr 29;389(10080):1756-1770. doi: 10.1016/S0140-6736(16)32126-2. Epub 2016 Dec 1.

  PMID: 27914657 BACKGROUND

• Torres J, Mehandru S, Colombel JF, Peyrin-Biroulet L. Crohn's disease. Lancet. 2017 Apr 29;389(10080):1741-1755. doi: 10.1016/S0140-6736(16)31711-1. Epub 2016 Dec 1.

  PMID: 27914655 BACKGROUND

MeSH Terms

Conditions

Crohn Disease; Colitis, Ulcerative; Inflammatory Bowel Diseases

Interventions

Patient Reported Outcome Measures

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Health Care Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Services Research; Health Planning; Health Care Economics and Organizations; Patient Outcome Assessment; Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Health Care Evaluation Mechanisms; Public Health; Environment and Public Health

Central Study Contacts

Peter Bossuyt, MD PhD

CONTACT

+32 15 50 56 91; peter.bossuyt@imelda.be

Lieven Pouillon, MD

CONTACT

Study Design

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

Study Record Dates

• First Submitted: August 23, 2025
• First Posted: September 8, 2025
• Study Start: September 8, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)