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SELFIE study: Home or hospital-based analysis of stool calprotectin

Home or hospital-based analysis of stool calprotectin: assessing two methods for monitoring inflammatory bowel disease

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON24517
Enrollment
200
Registered
2015-03-23
Start date
2015-05-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammatory bowel disease, IBD, Crohn's disease, Ulcerative colitis

Interventions

In this study we want to compare the established Quantum Blue® method for measuring calprotectin with the new IBDocTM home-monitoring method. We wish to see whether they agree sufficiently for the new

Sponsors

University Medical Centre Groningen (UMCG)
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Eligible patients are those aged 12 to 19 years, with IBD diagnosed (according to the Porto criteria) more than 6 months before enrolment, who have a smartphone with access to internet, knowledge of the Dutch language, and an adult caregiver who is willing to actively support participation.

Exclusion criteria

Exclusion criteria: Patients will be excluded from the study when they have an ileostomy (as calprotectin cut-offs are not validated for small bowel feces), or when they are taking medication that may influence stool calprotectin levels (NSAIDs).

Design outcomes

Primary

MeasureTime frame
Agreement between IBDocTM result and the Quantum Blue result.

Secondary

MeasureTime frame
Agreement between IBDocTM at home and the result performed in the lab with the same extraction solution.

Contacts

Public ContactP.F. Rheenen, van

University Medical Center Groningen Beatrix Children's Hospital Dept. Pediatric Gastroenterology Hanzeplein 1

p.f.van.rheenen@umcg.nl+31 (0)50 3614151

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)