Effects of Lactobacillus Reuteri Plus Vitamin D3 in Children With Atopic Dermatitis

Study Overview
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Brief Summary
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The purpose of this study is to evaluate in a randomized, double-blinded, controlled trial, whether a new food supplement containing Lactobacillus reuteri DSM 17938 and vitamin D3 (Reuterin® D3) may improve the SCORAD in pediatric patients with mild to moderate atopic dermatitis

Detailed Description
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Recent evidence suggests that childhood allergy development can be linked to an imbalance of the intestinal microbiota. The probiotic bacteria, which contribute to the balance of the intestinal microflora, may play a key role in the modulation of the immune response, looking as a potential resource in the prevention or treatment of allergic disorders. In this study the investigators will recruit pediatric patients with atopic dermatitis of mild-to-moderate degree, for which the standard treatment consists in using an emollient cream and topical steroids in case of exacerbation. The investigators assume that participants can receive significant benefits from the addition to their standard treatment of a food supplement containing L. reuteri DSM 17938 and vitamin D3, which, thanks to their beneficial effects on intestinal microbiota and on modulation of the immune response, may compensate for the inadequate capacity of these patients to produce antimicrobial peptides in response to cutaneous aggressions, improving, therefore, the severity of the disease. 88 children of both sexes, between 1 and 4 years old, with a SCORAD of 25-50 will be selected as a part of routine outpatient visits at the Pediatric Allergy Department of the University Hospital of Verona. The study product (active or placebo) will be administered for 3 months, with a follow-up period of further 3 months. From all participants, at time 0 and after 3 months, blood and stool samples will be collected for the analysis of vitamin D and cathelicidin levels and for the analysis of microflora respectively.

Official Title
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Randomized Controlled Trial to Evaluate the Beneficial Effects of a Probiotic Food Supplement in Children With Atopic Dermatitis

Conditions
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Atopic Dermatitis

Intervention / Treatment
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* Dietary Supplement: Reuterin D3
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosis of atopic dermatitis of mild to moderate grade (SCORAD 25-50) signature of the informed consent from both parents or a legal representative Exclusion Criteria: presence of autoimmune diseases, immunodeficiency, inflammatory bowel diseases, cystic fibrosis, metabolic diseases use of immunosuppressive drugs and/or systemic corticosteroids in the previous 2 months use of antibiotics in the last 4 weeks use of probiotics and/or prebiotics in the last 2 weeks use of vitamin D in the last 4 weeks participation in other clinical trials

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 4 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Reuterin D3<br>Patients should take 10 drops once a day during meals for 3 months | Dietary Supplement: Reuterin D3<br>* Lactobacillus reuteri DSM 17938 (10E8 CFU in 5 drops), Vitamin D3 (400 IU in 5 drops), sunflower oil, medium chain triglycerides, silicon dioxide<br>|
| Placebo Comparator: Placebo<br>Patients should take 10 drops once a day during meals for 3 months | Dietary Supplement: Placebo<br>* sunflower oil, medium chain triglycerides, silicon dioxide<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SCORAD improvement | Improvement of the SCORAD compared to baseline | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vitamin D levels increase | Increase of the levels of Vit. D compared to baseline | 3 months | 
| LL-37 levels increase | Increase of the levels of cathelicidin compared to baseline | 3 months | 
| Changes in the fecal microflora | Changes in the fecal microflora compared to baseline | 3 months | 
| QoL improvement | Improvement of the child's quality of life | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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atopic dermatitis, probiotics, vitamin D3, L. reuteri