Serological Identification of Celiac Disease in Kids

Health, Subjective Clinical Trial

— SICK  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03966625
• Other study ID #: DSBUS
• Status: Completed
• Start date: November 4, 2019
• Est. completion date: July 1, 2021

Study information

• Verified date: December 2021
• Source: Sahlgrenska University Hospital, Sweden
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 496
• Est. completion date: July 1, 2021
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Diagnostic Test:
• tissue transglutaminase autoantibodies
celiac disease-specific autoantibodies

Locations

Country	Name	City	State
Sweden	BUMM Hisingen	Gothenburg
Sweden	Queen Slivia Children's Hosptial	Gothenburg

Sponsors (2)

Lead Sponsor	Collaborator
Sahlgrenska University Hospital, Sweden	Vastra Gotaland Region

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants diagnosed with celiac disease	Celiac disease diagnosed according to European pediatric (ESPGHAN) guidelines	Assessed after 6-12 months of follow-up
Secondary	Number of participants identified with celiac disease autoimmunity	Celiac disease autoimmunity defined by having two consecutive positive tests for tissue transglutaminase (TTG) autoantibodies	Assessed after performed two tests of TTG (apprx. 1-2 months after enrollment)