Serological Identification of Celiac Disease in Kids

Completed

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

• Registration Number: NCT03966625
• Lead Sponsor: Sahlgrenska University Hospital, Sweden

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-05-25
• Study First Submitted QC: 2019-05-25
• Study First Posted: 2019-05-29
• Study Start: 2019-11-04
• Primary Completion: 2021-07-01
• Study Completion: 2021-07-01
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-08
• Last Update Posted: 2021-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 496

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of participants diagnosed with celiac disease	Assessed after 6-12 months of follow-up	Celiac disease diagnosed according to European pediatric (ESPGHAN) guidelines

Secondary Outcome Measures

Name	Time	Method
Number of participants identified with celiac disease autoimmunity	Assessed 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

Trial Locations

Locations (2)

BUMM Hisingen; 🇸🇪 Gothenburg, Sweden

Queen Slivia Children's Hosptial; 🇸🇪 Gothenburg, Sweden