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OpenTrials
Completed

NCT Number: NCT03966625

Serological Identification of Celiac Disease in Kids

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.

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Key information

Conditions

Celiac Disease in Children Growth Delay Health, Subjective Pediatric Disorder

Age range

2 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

BUMM Hisingen, Gothenburg, Sweden

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

tissue transglutaminase autoantibodies

Diagnostic Test

celiac disease-specific autoantibodies

Primary outcomes

  1. Number of participants diagnosed with celiac disease

    Time frame: Assessed after 6-12 months of follow-up

    Celiac disease diagnosed according to European pediatric (ESPGHAN) guidelines

Secondary outcomes

  1. Number of participants identified with celiac disease autoimmunity

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Sahlgrenska University Hospital

Other

Collaborators

  • Vastra Gotaland Region

Registry information

Official study title

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

Acronym: SICK

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
May 29, 2019
Registry last updated
Dec 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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