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

Nóos

Status: Completed

Conditions: Atopic Dermatitis

Treatments: Dietary Supplement: Reuterin D3; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02945683

ATOPIA_D3

Details and patient eligibility

About

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

Full description

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.

Enrollment: 88 patients

Sex: All

Ages: 1 to 4 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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88 participants in 2 patient groups, including a placebo group

Reuterin D3

Active Comparator group

Description:

Patients should take 10 drops once a day during meals for 3 months

Treatment:

Dietary Supplement: Reuterin D3

Placebo

Placebo Comparator group

Description:

Patients should take 10 drops once a day during meals for 3 months

Treatment:

Dietary Supplement: Placebo