Celiac Disease Prevention With Probiotics

Study Overview
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Brief Summary
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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.

Official Title
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Celiac Disease Prevention With Probiotics

Conditions
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Celiac Disease in Children

Intervention / Treatment
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* Dietary Supplement: Probiotic
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Probiotic Group<br>The participants in the Probiotic group were provided with dietary supplements in the form as sachets with freeze dried bacteria (active lactobacilli culture) mixed with maltodextrin for daily intake (1 per day). The powder was dissolved in water or other non-alcoholic cold drink mixed with fruit before ingestion. The probiotic product consisted of two different bacterial strains. | Dietary Supplement: Probiotic<br> <br> |
| Placebo Comparator: Placebo Group<br>The participants in the Placebo group were provided with dietary supplements in the form as sachets with maltodextrin for daily intake (1 per day). | Dietary Supplement: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tissue transglutaminase autoantibodies (tTGA) | To study levels of tTGA in children with ongoing celiac disease autoimmunity | 6 months |