Trial | NCT02945683  Report issue

Title

Effects of Lactobacillus Reuteri Plus Vitamin D3 in Children With Atopic Dermatitis
Randomized Controlled Trial to Evaluate the Beneficial Effects of a Probiotic Food Supplement in Children With Atopic Dermatitis

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    vitamin d3 ...

  • Study Participants

    88
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
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.
Study Started
Feb 28
2015
Primary Completion
Feb 28
2017
Study Completion
Feb 28
2018
Last Update
Mar 22
2023

Dietary Supplement Reuterin D3

Lactobacillus reuteri DSM 17938 (10E8 CFU in 5 drops), Vitamin D3 (400 IU in 5 drops), sunflower oil, medium chain triglycerides, silicon dioxide

Dietary Supplement Placebo

sunflower oil, medium chain triglycerides, silicon dioxide

Reuterin D3 Active Comparator

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

Placebo Placebo Comparator

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

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
No Results Posted