GRINCH: Groningen Initiative on Reference Intervals in Children

Inflammatory Bowel Disease Clinical Trial

— GRINCH  

Official title:

GRINCH: Groningen Initiative on Reference Intervals in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02588222
• Other study ID #: 201500284
• Status: Completed
• Phase: N/A
• First received: August 7, 2015
• Last updated: May 11, 2016
• Start date: June 2015
• Est. completion date: May 2016

Study information

• Verified date: May 2016
• Source: University Medical Center Groningen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: May 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Years to 18 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Inflammatory Bowel Disease
• Inflammatory Bowel Diseases

Locations

Country	Name	City	State
Netherlands	University Medical Center Groningen	Groningen

Sponsors (2)

Lead Sponsor	Collaborator
University Medical Center Groningen	Cisbio Bioassays

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Levels of Calgranulin C (S100A12) in healthy children		One measurement at baseline	No