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

Not Applicable

Completed

• Conditions: Atopic Dermatitis
• Interventions: Dietary Supplement: Reuterin D3; Dietary Supplement: Placebo

• Registration Number: NCT02945683
• Lead Sponsor: Noos S.r.l.

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.

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2016-10-24
• Study First Submitted QC: 2016-10-24
• Study First Posted: 2016-10-26
• Primary Completion: 2017-02
• Study Completion: 2018-02
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-21
• Last Update Posted: 2023-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Reuterin D3	Reuterin D3	Patients should take 10 drops once a day during meals for 3 months
Placebo	Placebo	Patients should take 10 drops once a day during meals for 3 months

Primary Outcome Measures

Name	Time	Method
SCORAD improvement	3 months	Improvement of the SCORAD compared to baseline

Secondary Outcome Measures

Name	Time	Method
Changes in the fecal microflora	3 months	Changes in the fecal microflora compared to baseline
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

Trial Locations

Locations (1)

Policlinico G.B. Rossi; 🇮🇹 Verona, Italy