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GRINCH: Groningen Initiative on Reference Intervals in Children

GRINCH: Groningen Initiative on Reference Intervals in Children

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02588222
Acronym
GRINCH
Enrollment
120
Registered
2015-10-27
Start date
2015-06-30
Completion date
2016-05-31
Last updated
2016-05-12

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

Conditions

Inflammatory Bowel Disease

Brief summary

The purpose of this study is to establish reliable reference intervals for fecal S100A12 in healthy children.

Detailed description

RATIONALE S100A12 (calgranulin C) is a cytoplasmic protein secreted exclusively by activated neutrophils. It can be measured in stools and elevated levels are observed in children with inflammatory bowel disease. The protein is stable in stool samples for up to seven days at room temperature, which allows collection at home and potential delays in transport to the laboratory. S100A12 could be used as a marker to discriminate between pediatric inflammatory and functional gastro-intestinal conditions, and prevent children with a low probability of inflammation from unnecessary endoscopic procedures. Until now a reliable reference interval for healthy children is lacking. OBJECTIVE To establish reliable reference intervals for fecal S100A12 in healthy children. TIME FRAME Healthy children will be asked to send in one feces sample anonymously during the inclusion period. The investigators expect that the required 120 samples will be collected before December 2015. There will be no follow up of patients.

Interventions

None listed

Sponsors

Cisbio Bioassays
CollaboratorINDUSTRY
University Medical Center Groningen
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
Yes

Inclusion criteria

healthy volunteers: * Age: 6-18 years old

Exclusion criteria

* Treated for any gastro-intestinal symptoms * Diarrhea in the last week before the collection of the feces sample * Fever in the last week before collection of the feces sample * Use of NSAIDs of Proton pump inhibitors in the last 14 days before collection feces sample.

Design outcomes

Primary

MeasureTime frame
Levels of Calgranulin C (S100A12) in healthy childrenOne measurement at baseline

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026