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Serological Identification of Celiac Disease in Kids

NCT03966625 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 496

Last updated 2021-12-09

No results posted yet for this study

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

DIAGNOSTIC_TEST

tissue transglutaminase autoantibodies

celiac disease-specific autoantibodies

Sponsors & Collaborators

  • Vastra Gotaland Region

    collaborator OTHER_GOV

  • Sahlgrenska University Hospital

    lead OTHER

Eligibility

Min Age
2 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-11-04
Primary Completion
2021-07-01
Completion
2021-07-01

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03966625 on ClinicalTrials.gov