Policlinico G.B. Rossi
Verona, 37134, Italy
NCT Number: NCT02945683
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
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Notify Me1 year–4 year
All sexes
Interventional
Not applicable
Verona, 37134, Italy
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Lactobacillus reuteri DSM 17938 (10E8 CFU in 5 drops), Vitamin D3 (400 IU in 5 drops), sunflower oil, medium chain triglycerides, silicon dioxide
sunflower oil, medium chain triglycerides, silicon dioxide
Time frame: 3 months
Improvement of the SCORAD compared to baseline
Time frame: 3 months
Increase of the levels of Vit. D compared to baseline
Time frame: 3 months
Increase of the levels of cathelicidin compared to baseline
Time frame: 3 months
Changes in the fecal microflora compared to baseline
Time frame: 3 months
Improvement of the child's quality of life
Time frame: 3 months
Evaluation of the child's eating habits
Noos S.r.l.
Industry
Randomized Controlled Trial to Evaluate the Beneficial Effects of a Probiotic Food Supplement in Children With Atopic Dermatitis
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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