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OpenTrials
Completed

NCT Number: NCT02588222

GRINCH: Groningen Initiative on Reference Intervals in Children

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

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Key information

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Medical Center Groningen

Groningen, 9700RB, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Levels of Calgranulin C (S100A12) in healthy children

    Time frame: One measurement at baseline

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Collaborators

  • Cisbio Bioassays

Registry information

Acronym: GRINCH

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Oct 27, 2015
Registry last updated
May 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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