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Clinical Trials in Sweden / NCT03562221
Active, not recruiting Not applicable

Prevention of Celiac Disease in Skåne

NCT03562221 · tracked via the Priya Life Science Sweden tracker
Sponsor
Lund University
Phase
Not applicable
Started
2018-12-04
Last updated
2026-09-08

Condition(s) studied

Celiac Disease in Children

Investigational drug(s) / intervention(s)

Gluten free dietProbioticsPlacebo

Gluten free diet: Controlled gluten free diet

Probiotics: Capsules

Placebo: Capsules

Study summary

This study aims to investigate the impact of being on a gluten free diet the first three years of life compared to a daily intake of a probiotic supplementation or placebo on the risk of developing celiac disease autoimmunity or celiac disease in genetically susceptible children.

This is a three-arm (1:1:1) randomized trial where study participants are randomly allocated to one of the three study groups before the age of 4 months. Regular clinical visits (4 times/year) during the intervention phase and yearly there after, up to the age of 7 years.

Eligibility

Sex
ALL
Min age
4 Months
Max age
4 Months
Healthy volunteers
Accepted
Inclusion Criteria: * Children screened positive for human leucocyte antigen (HLA) DR3-DQ2/DR3-DQ2 * Children must be enrolled to the study by 4 months of age (before gluten consumption has started). Exclusion Criteria: * Congenital chronic disorder where intervention with diet or probiotics may be affected. * Written consent from both caregivers are missing

Primary outcome measure(s)

  • Number of children tested positive for persistent tissue transglutaminase (tTG) autoantibodies, defined as celiac disease autoimmunity — from 4 months of age up until 7 years of age
    Radioligand binding assays (RBA) will be used to measure tTG autoantibodies in serum samples collected every third months up until the age of 3 years and then annually up until the age of 7 years.

Trial sites (1)

FacilityCityRegionStatus
Clinical Research Center (CRC), Bldng 60:11 Malmö Sweden

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Other trials for the same condition

Gluten Reduction and Risk of Celiac Disease Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03562221 on ClinicalTrials.gov ↗ ← All trials in Sweden