NCT03966625

Serological Identification of Celiac Disease in Kids

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 496 (actual)
• Sponsor: Sahlgrenska University Hospital · Academic / Other
• Sex: All
• Age: 2 Years – 17 Years
• Healthy volunteers: Accepted

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.

Conditions

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

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	tissue transglutaminase autoantibodies	celiac disease-specific autoantibodies

Timeline

• Start date: 2019-11-04
• Primary completion: 2021-07-01
• Completion: 2021-07-01
• First posted: 2019-05-29
• Last updated: 2021-12-09

Locations

2 sites across 1 country: Sweden