Atopic Dermatitis
Conditions
Keywords
atopic dermatitis, probiotics, vitamin D3, L. reuteri
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.
Interventions
DIETARY_SUPPLEMENTReuterin 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_SUPPLEMENTPlacebo
sunflower oil, medium chain triglycerides, silicon dioxide
Sponsors
Noos S.r.l.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
1 Years to 4 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SCORAD improvement | 3 months | Improvement of the SCORAD compared to baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| QoL improvement | 3 months | Improvement of the child's quality of life |
| Vitamin D levels increase | 3 months | Increase of the levels of Vit. D compared to baseline |
| LL-37 levels increase | 3 months | Increase of the levels of cathelicidin compared to baseline |
| Changes in the fecal microflora | 3 months | Changes in the fecal microflora compared to baseline |
Other
| Measure | Time frame | Description |
|---|---|---|
| Food Frequency Questionnaire | 3 months | Evaluation of the child's eating habits |
Countries
Italy
Outcome results
None listed