Celiac Disease in ChildrenSICKNCT03966625
Serological Identification of Celiac Disease in Kids
An observational study of Celiac Disease in Children and Pediatric Disorder, run by Sahlgrenska University Hospital at 2 sites in Sweden.
Trial summary
The investigators aim to examine the feasibility of incorporating serological celiac disease (CD) screening into general pediatric outpatient clinics in Sweden and through structured monitoring examine the effects of diagnosing and treating screening-detected CD. Read more about this study
- Who is it for?
- Ages 2 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Celiac Disease in Children, Pediatric Disorder, Health, Subjective
- What is being tested?
- tissue transglutaminase autoantibodies
- How many people
- 496 participants
- Where
- 2 sitesSweden
- Study dates
- 4 Nov 2019to 1 Jul 2021
- 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 2 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Patients at pediatric outpatient clinics in Gothenburg metro area
Who may be able to join
- Aged 2-17 years old
- Patient at pediatric outpatient clinics in Gothenburg metro area
- Parental and adolescent consent to screening
Who cannot join
- Established celiac disease diagnosis
- Type 1 diabetes
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
Queen Slivia Children's Hosptial
Gothenburg, 41650
BUMM Hisingen
Gothenburg
About this study
Official title: Serological Identification of Celiac Disease in Kids (Swedish: Screening för Celiaki på Barnmottagning)
The investigators aim to examine the feasibility of incorporating serological celiac disease (CD) screening into general pediatric outpatient clinics in Sweden and through structured monitoring examine the effects of diagnosing and treating screening-detected CD.
Screening will be tailored to general pediatric outpatient clinics in the Gothenburg metropolitan area with the goal to screen 1000 children over four months. Screening for CD will be carried out by measuring tissue transglutaminase autoantibodies (TGA) in blood. Children who are persistently TGA positive will be enrolled into a 6-12-month follow-up protocol responsible for diagnosing CD, installation of gluten-free diet and to assess their short-term impact upon the child's wellbeing. Other components to assess include (I) the feasibility to incorporate CD screening into busy pediatric practices; (II) parental/child interest in, and satisfaction with, participating in a CD screening program and (III) identifying key considerations for a possible scaled-up, broad-based, CD screening.
- Being tested
- tissue transglutaminase autoantibodies
- Keywords
- screening
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tissue transglutaminase autoantibodiesDiagnostic test
celiac disease-specific autoantibodies
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants diagnosed with celiac disease
Celiac disease diagnosed according to European pediatric (ESPGHAN) guidelines
Measured: Assessed after 6-12 months of follow-up
Secondary outcomes (1)
Number of participants identified with celiac disease autoimmunity
Celiac disease autoimmunity defined by having two consecutive positive tests for tissue transglutaminase (TTG) autoantibodies
Measured: Assessed after performed two tests of TTG (apprx. 1-2 months after enrollment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2019
- Study start4 Nov 2019
- Primary completion1 Jul 2021
- Study completion1 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Celiac Disease in ChildrenStudies of the same condition, open and under way.
- More trials run by Sahlgrenska University HospitalThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 496 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Vastra Gotaland Region
- Responsible party
- Principal investigator, Karl Mårild, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03966625
- Sponsor's protocol ID
- DSBUS
- Acronym
- SICK
- Status last verified
- Dec 2021
- First submitted
- 25 May 2019
- Last updated
- 9 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared in accordance with the ethical approval of this study
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serological Identification of Celiac Disease in Kids (Swedish: Screening för Celiaki på Barnmottagning)
- ClinicalTrials.gov ID
- NCT03966625
- Acronym / sponsor ID
- SICK / DSBUS
- Keywords
- screening
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 496 participants (actual)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Collaborators
- Vastra Gotaland Region
- Study start
- 4 Nov 2019 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 29 May 2019 (actual)
- 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 investigators aim to examine the feasibility of incorporating serological celiac disease (CD) screening into general pediatric outpatient clinics in Sweden and through structured monitoring examine the effects of diagnosing and treating screening-detected CD.
Screening will be tailored to general pediatric outpatient clinics in the Gothenburg metropolitan area with the goal to screen 1000 children over four months. Screening for CD will be carried out by measuring tissue transglutaminase autoantibodies (TGA) in blood. Children who are persistently TGA positive will be enrolled into a 6-12-month follow-up protocol responsible for diagnosing CD, installation of gluten-free diet and to assess their short-term impact upon the child's wellbeing. Other components to assess include (I) the feasibility to incorporate CD screening into busy pediatric practices; (II) parental/child interest in, and satisfaction with, participating in a CD screening program and (III) identifying key considerations for a possible scaled-up, broad-based, CD screening.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Patients at pediatric outpatient clinics in Gothenburg metro area
Key inclusion criteria (3 listed)
- Aged 2-17 years old
- Patient at pediatric outpatient clinics in Gothenburg metro area
- Parental and adolescent consent to screening
Key exclusion criteria (2 listed)
- Established celiac disease diagnosis
- Type 1 diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tissue transglutaminase autoantibodiesceliac disease-specific autoantibodies | Diagnostic test | – |
Primary outcome
Number of participants diagnosed with celiac disease
Time frame: Assessed after 6-12 months of follow-up
Celiac disease diagnosed according to European pediatric (ESPGHAN) guidelines
1 secondary outcome
Number of participants identified with celiac disease autoimmunity
Time frame: Assessed after performed two tests of TTG (apprx. 1-2 months after enrollment)
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 9 Dec 2021.
- Individual participant dataSharing planned: No. Individual participant data will not be shared in accordance with the ethical approval of this study
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Assessment of Nutritional Status in Celiac Disease Using Muscle Ultrasound in Pediatric Patients.
Celiac Disease in Children, Nutritional Assessment
Active, not recruiting
Celiac Disease in Childhood-Adulthood Transition
Celiac Disease, Celiac Disease in Children
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Immune Responses to Gluten
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Effect of Adherence to a Gluten-Free Diet on Cognitive and Motor Dual-Task Performance in Adolescents Diagnosed With Celiac Disease
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Celiac Disease in Children and Pediatric Disorder, run by Sahlgrenska University Hospital at 2 sites in Sweden.
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 3 inclusion and 2 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 9 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. 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?
Number of participants diagnosed with celiac disease (time frame: Assessed after 6-12 months of follow-up). 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 9 Dec 2021; AzTrials last refreshed its copy on 7 Nov 2026.