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


- candidate number21839
- NTR NumberNTR5133
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR23-mrt-2015
- Secondary IDs2014.466. MEtc UMCG
- Public TitleSELFIE study: Home or hospital-based analysis of stool calprotectin
- Scientific TitleHome or hospital-based analysis of stool calprotectin: assessing two methods for monitoring inflammatory bowel disease
- ACRONYMSELFIE-study
- hypothesis
- Healt Condition(s) or Problem(s) studiedIBD, Crohn's disease, Ulcerative Colitis
- Inclusion criteriaEligible 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 criteriaPatients 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).
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- Type[default]
- Studytypeintervention
- planned startdate 1-mei-2015
- planned closingdate1-mei-2016
- Target number of participants200
- InterventionsIn 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 to replace the old.
- Primary outcomeAgreement between IBDocTM result and the Quantum Blue result.
- Secondary outcomeAgreement between IBDocTM at home and the result performed in the lab with the same extraction solution.
- Timepoints12 months
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESMD. PhD. P.F. Rheenen, van
- CONTACT for SCIENTIFIC QUERIESMD. P.F. Rheenen, van
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
Bühlmann Laboratories AG, Switzerland
- PublicationsN/A
- Brief summary
- Main changes (audit trail)
- RECORD23-mrt-2015 - 30-apr-2015


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