Serological Identification of Celiac Disease in Kids

NCT03966625 | Completed

• 1 other identifier: DSBUS
• Study Type: observational
• Target: 496
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Keywords

screening

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of participants identified with celiac disease autoimmunity

  Assessed after performed two tests of TTG (apprx. 1-2 months after enrollment)

Interventions

tissue transglutaminase autoantibodies DIAGNOSTIC_TEST

celiac disease-specific autoantibodies

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Patients at pediatric outpatient clinics in Gothenburg metro area

You may qualify if:

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

You may not qualify if:

• Established celiac disease diagnosis
• Type 1 diabetes

Sponsors & Collaborators

• Sahlgrenska University Hospital: lead
• Vastra Gotaland Region: collaborator

Study Sites (2)

Queen Slivia Children's Hosptial

Gothenburg, 41650, Sweden

Location

BUMM Hisingen

Gothenburg, Sweden

Location

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatrican, associate professor

Study Record Dates

• First Submitted: May 25, 2019
• First Posted: May 29, 2019
• Study Start: November 4, 2019
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2021
• Last Updated: December 9, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

SE (2)