Serological Identification of Celiac Disease in Kids | NCT03966625

Studies
Serological Identification of Celiac Disease in Kids

NCT03966625

Sponsor

Sahlgrenska University Hospital

Status

Completed

Last Update Posted

Dec 9, 2021Actual

Enrollment

496Actual

Phase

Not provided

Conditions

Celiac Disease in Children
Pediatric Disorder
Health, Subjective
Growth Delay

Interventions

tissue transglutaminase autoantibodies

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 4, 2019Actual

Primary Completion Date

Jul 1, 2021Actual

Completion Date

Jul 1, 2021Actual

First Submitted Date

May 25, 2019

First Submission Date that Met QC Criteria

May 25, 2019

First Posted Date

May 29, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 8, 2021

Last Update Posted Date

Dec 9, 2021Actual

Name	Class
Vastra Gotaland Region	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

496Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
tissue transglutaminase autoantibodies	Diagnostic Test	celiac disease-specific autoantibodies

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Number of participants identified with celiac disease autoimmunity	Celiac disease autoimmunity defined by having two consecutive positive tests for tissue transglutaminase (TTG) autoantibodies	Assessed after performed two tests of TTG (apprx. 1-2 months after enrollment)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

17 Years

Standard Ages

Child

Study Population

Patients at pediatric outpatient clinics in Gothenburg metro area

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Queen Slivia Children's Hosptial		Gothenburg		41650	Sweden
BUMM Hisingen

IPD Sharing Statement Module

Plan to Share IPD

Description

Individual participant data will not be shared in accordance with the ethical approval of this study

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided