GRINCH: Groningen Initiative on Reference Intervals in Children (GRINCH)

May 11, 2016 updated by: P.F. van Rheenen, University Medical Center Groningen
The purpose of this study is to establish reliable reference intervals for fecal S100A12 in healthy children.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Groningen, Netherlands, 9700RB
        • University Medical Center Groningen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Healthy children, aged 6-18 years old

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Healthy children
Healthy children, aged 6-18 years old.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Levels of Calgranulin C (S100A12) in healthy children
Time Frame: One measurement at baseline
One measurement at baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Center Groningen

Collaborators

Cisbio Bioassays

Investigators

  • Principal Investigator: Patrick van Rheenen, MD PhD, University Medical Center Groningen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (ACTUAL)

April 1, 2016

Study Completion (ACTUAL)

May 1, 2016

Study Registration Dates

First Submitted

August 7, 2015

First Submitted That Met QC Criteria

October 26, 2015

First Posted (ESTIMATE)

October 27, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

May 12, 2016

Last Update Submitted That Met QC Criteria

May 11, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201500284

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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