Clinical trial NCT02945683: Effects of Lactobacillus Reuteri Plus Vitamin D3 in Children With Atopic Dermatitis
Official title: Randomized Controlled Trial to Evaluate the Beneficial Effects of a Probiotic Food Supplement in Children With Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atopic Dermatitis
Keywords: atopic dermatitis, probiotics, vitamin D3, L. reuteri
Lead sponsor: Noos S.r.l.
Sponsor class: INDUSTRY
First posted: 2016-10-26
Enrollment: 88
Sex: ALL
Minimum age (years): 1
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: SCORAD improvement
timeFrame: 3 months
Secondary outcomes:
measure: Vitamin D levels increase
timeFrame: 3 months
measure: LL-37 levels increase
timeFrame: 3 months
measure: Changes in the fecal microflora
timeFrame: 3 months
measure: QoL improvement
timeFrame: 3 months
Other outcomes:
measure: Food Frequency Questionnaire
timeFrame: 3 months
Locations:
city: Verona
country: Italy
facility: Policlinico G.B. Rossi
Study officials:
affiliation: Policlinico G.B. Rossi, Head of the Pediatric Department
name: Attilio Boner, Professor
role: PRINCIPAL_INVESTIGATOR
References: