Serological Identification of Celiac Disease in Kids

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

496 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-11-04

Study Completion Date

2021-07-01

Brief Summary

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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

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Conditions

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Celiac Disease in Children Pediatric Disorder Health, Subjective Growth Delay

Keywords

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screening

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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tissue transglutaminase autoantibodies

celiac disease-specific autoantibodies

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Established celiac disease diagnosis
* Type 1 diabetes

Minimum Eligible Age

2 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Karl Mårild

Pediatrican, associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Queen Slivia Children's Hosptial

Gothenburg, , Sweden

Site Status

BUMM Hisingen

Gothenburg, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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DSBUS

Identifier Type: -

Identifier Source: org_study_id