Cytokine Profile in Children With Celiac Disease

Study Overview
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Brief Summary
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Celiac disease (CD) is an immune-mediated systemic disease that is elicited by consumption of gluten and related prolamines in genetically susceptible individuals. Not only genetic but also environmental factors play an important role in CD pathogenesis. CD patients have imbalance in the gut microbiota, they have reduced number of Bididobacterium species in feces and biopsies. Up till now, only effective treatment for CD is life long adherence to gluten free diet. If gluten free diet is not strict that leads over the years to complications of disease, such as autoimmune diseases, psychiatric diseases, osteoporosis etc. That may be caused by continuous recirculation of activated immune cells between the inflamed organ and the periphery. To avoid complications of disease in long term the investigators want to test specific probiotic bacteria from Bifidobacteria genus, that has has been in vitro studies recognized as anti-inflammatory. Hypothesis Children with celiac disease on gluten free diet have a higher level of pro-inflammatory cytokine (TNF-alpha) and anti-inflammatory cytokine (IL-10) in comparison with healthy controls. 3 months after daily probiotic consumption TNF-alpha level decrease and IL-10 level increase. In the investigators research will be selected 70 children, age from 2 to 18 years, divided in different groups: Group: 25 children with celiac disease on GFD for at least 3 months and will receive probiotic for 3 months. Group: 25 children with celiac disease on GFD for at least 3 months and will receive placebo for 3 months. Group: 20 healthy children

Official Title
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Exploratory, Placebo-controlled Study on the Effects of Bifidobacterium Breve in Children With Celiac Disease

Conditions
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Celiac Disease

Intervention / Treatment
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* Drug: Bifidobacterium breve
* Drug: Placebo (for Bifidobacterium breve)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: celiac disease on gluten free diet Exclusion Criteria: acute or chronic diseases, permanent use of medication and ingestion of antibiotics at least one month prior to study

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 18 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bifidobacterium breve<br>Bifidobacterium breve BR03 and B632 powder containing 10/9 CFU daily dosage in a period of 3 months | Drug: Bifidobacterium breve<br> <br> |
| Active Comparator: Placebo<br>Placebo in the same powder packages as Bifidobacterium breve | Drug: Placebo (for Bifidobacterium breve)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum TNF-alpha decrease after Bifidobacterium breve daily consumption in children with celiac disease |  | 3 months |