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Serological Identification of Celiac Disease in Kids

Serological Identification of Celiac Disease in Kids (Swedish: Screening för Celiaki på Barnmottagning)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03966625
Acronym
SICK
Enrollment
496
Registered
2019-05-29
Start date
2019-11-04
Completion date
2021-07-01
Last updated
2021-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Celiac Disease in Children, Growth Delay, Health, Subjective, Pediatric Disorder

Keywords

screening

Brief 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. 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.

Interventions

DIAGNOSTIC_TESTtissue transglutaminase autoantibodies

celiac disease-specific autoantibodies

Sponsors

Vastra Gotaland Region
CollaboratorOTHER_GOV
Sahlgrenska University Hospital
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
2 Years to 17 Years
Healthy volunteers
Yes

Inclusion criteria

* Aged 2-17 years old * Patient at pediatric outpatient clinics in Gothenburg metro area * Parental and adolescent consent to screening

Exclusion criteria

for serological screening: * Established celiac disease diagnosis * Type 1 diabetes

Design outcomes

Primary

MeasureTime frameDescription
Number of participants diagnosed with celiac diseaseAssessed after 6-12 months of follow-upCeliac disease diagnosed according to European pediatric (ESPGHAN) guidelines

Secondary

MeasureTime frameDescription
Number of participants identified with celiac disease autoimmunityAssessed after performed two tests of TTG (apprx. 1-2 months after enrollment)Celiac disease autoimmunity defined by having two consecutive positive tests for tissue transglutaminase (TTG) autoantibodies

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026