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Completed

NCT Number: NCT02945683

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

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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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Reuterin D3

Dietary Supplement

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

Placebo

Dietary Supplement

sunflower oil, medium chain triglycerides, silicon dioxide

Primary outcomes

  1. SCORAD improvement

    Time frame: 3 months

    Improvement of the SCORAD compared to baseline

Secondary outcomes

  1. Vitamin D levels increase

    Time frame: 3 months

    Increase of the levels of Vit. D compared to baseline

  2. LL-37 levels increase

    Time frame: 3 months

    Increase of the levels of cathelicidin compared to baseline

  3. Changes in the fecal microflora

    Time frame: 3 months

    Changes in the fecal microflora compared to baseline

  4. QoL improvement

    Time frame: 3 months

    Improvement of the child's quality of life

Other outcomes

  1. Food Frequency Questionnaire

    Time frame: 3 months

    Evaluation of the child's eating habits

Sponsors and collaborators

Lead sponsor

Noos S.r.l.

Industry

Registry information

Official study title

Randomized Controlled Trial to Evaluate the Beneficial Effects of a Probiotic Food Supplement in Children With Atopic Dermatitis

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
Oct 26, 2016
Registry last updated
Mar 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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