NCT02588222

GRINCH: Groningen Initiative on Reference Intervals in Children

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 120 (actual)
• Sponsor: University Medical Center Groningen · Academic / Other
• Sex: All
• Age: 6 Years – 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Inflammatory Bowel Disease

Timeline

• Start date: 2015-06-01
• Primary completion: 2016-04-01
• Completion: 2016-05-01
• First posted: 2015-10-27
• Last updated: 2016-05-12

Locations

1 site across 1 country: Netherlands