NCT02588222

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 7, 2015

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 27, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

May 12, 2016

Status Verified

May 1, 2016

Enrollment Period

10 months

First QC Date

August 7, 2015

Last Update Submit

May 11, 2016

Conditions

Inflammatory Bowel Disease

Outcome Measures

Primary Outcomes (1)

  • Levels of Calgranulin C (S100A12) in healthy children

    One measurement at baseline

Study Arms (1)

Healthy children

Healthy children, aged 6-18 years old.

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Healthy children, aged 6-18 years old

You may qualify if:

  • Age: 6-18 years old

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Groningen

Groningen, 9700RB, Netherlands

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

feces samples

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Officials

  • Patrick van Rheenen, MD PhD

    University Medical Center Groningen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

August 7, 2015

First Posted

October 27, 2015

Study Start

June 1, 2015

Primary Completion

April 1, 2016

Study Completion

May 1, 2016

Last Updated

May 12, 2016

Record last verified: 2016-05

Locations

NL(1)