Inflammatory Bowel DiseaseGRINCHNCT02588222
GRINCH: Groningen Initiative on Reference Intervals in Children
An observational study of Inflammatory Bowel Disease, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
The purpose of this study is to establish reliable reference intervals for fecal S100A12 in healthy children. Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammatory Bowel Disease
- How many people
- 120 participants
- Where
- 1 siteNetherlands
- Study dates
- Jun 2015to May 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Healthy children, aged 6-18 years old
Who may be able to join
- Age: 6-18 years old
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to establish reliable reference intervals for fecal S100A12 in healthy children.
Read the 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
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy children | Healthy children, aged 6-18 years old. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Levels of Calgranulin C (S100A12) in healthy children
Measured: One measurement at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2015 (estimated)
- Study startJun 2015
- Primary completionApr 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseaseStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Collaborators
- Cisbio Bioassays
- Responsible party
- Principal investigator, P.F. van Rheenen, University Medical Center Groningen
- Investigators
- Patrick van Rheenen, MD PhD, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02588222
- Sponsor's protocol ID
- 201500284
- Acronym
- GRINCH
- Status last verified
- May 2016
- First submitted
- 7 Aug 2015
- Last updated
- 12 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GRINCH: Groningen Initiative on Reference Intervals in Children
- ClinicalTrials.gov ID
- NCT02588222
- Acronym / sponsor ID
- GRINCH / 201500284
- Conditions
- Inflammatory Bowel Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Collaborators
- Cisbio Bioassays
- Study start
- Jun 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 27 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy children | – | –Healthy children, aged 6-18 years old. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Healthy children, aged 6-18 years old
Key inclusion criteria (1 listed)
- Age: 6-18 years old
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Levels of Calgranulin C (S100A12) in healthy children
Time frame: One measurement at baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick van Rheenen, MD PhD principal investigator
University Medical Center Groningen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Disease, run by University Medical Center Groningen at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Levels of Calgranulin C (S100A12) in healthy children (time frame: One measurement at baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2016.