Serological Identification of Celiac Disease in Kids (SICK)

Sahlgrenska University Hospital

Status: Completed

Conditions: Pediatric Disorder; Celiac Disease in Children; Health, Subjective; Growth Delay

Treatments: Diagnostic Test: tissue transglutaminase autoantibodies

Study type: Observational

Funder types: Other

Identifiers

NCT03966625

DSBUS

Details and patient eligibility

About

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.

Enrollment: 496 patients

Sex: All

Ages: 2 to 17 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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