Celiac Disease in Children
Conditions
Brief summary
Background/Aim: Celiac disease is a common immune-mediated disorder, and the only currently available treatment is a gluten-free diet. Recent studies have shown several probiotics to carry properties that might positively influence the immunological activity in celiac patients. The aim of the present study is to investigate how daily consumption of probiotics would affect levels of tissue transglutaminase autoantibodies (tTGA), markers of celiac disease autoimmunity in the periphery, as compared to placebo in children at genetic risk for celiac disease. Methods: Between 2012 and 2015, 90 children were recruited from two ongoing prospective celiac disease screening studies at the Skåne University Hospital, Sweden. Participants were randomized to either daily consumption of 2 lactobacilli strains or placebo for the duration of 6 months. Blood samples were drawn at 0, 3 and 6 months and analyzed for both IgA-tTGA and IgG-tTGA using radioligand binding assays.
Interventions
DIETARY_SUPPLEMENTProbiotic
DIETARY_SUPPLEMENTPlacebo
Sponsors
Lund University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Double-blind
Eligibility
Sex/Gender
ALL
Age
2 Years to 12 Years
Healthy volunteers
Yes
Inclusion criteria
* Carrier of any of the HLA-types DQ2 and/or DQ8 associated with celiac disease. * Screened positive for tissue transglutaminase autoantibodies (tTGA) in at least 2 consecutive blood draws (\<30U/ml). * No celiac disease diagnose * Currently on a normal gluten-containing diet
Exclusion criteria
* Screened positive for Type 1 diabetes associated autoantibodies (GADA, IAA, IA-2A, ZnT8A).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tissue transglutaminase autoantibodies (tTGA) | 6 months | To study levels of tTGA in children with ongoing celiac disease autoimmunity |
Outcome results
None listed