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

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

Study Overview

• Status: Completed
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Reuterin D3

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 Type: Interventional
• Enrollment (Actual): 88
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Verona, Italy, 37134
    • Policlinico G.B. Rossi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 4 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Reuterin D3; Patients should take 10 drops once a day during meals for 3 months	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
Placebo Comparator: Placebo; Patients should take 10 drops once a day during meals for 3 months	Dietary supplement: Placebo; sunflower oil, medium chain triglycerides, silicon dioxide

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SCORAD improvement	Improvement of the SCORAD compared to baseline	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vitamin D levels increase	Increase of the levels of Vit. D compared to baseline	3 months
LL-37 levels increase	Increase of the levels of cathelicidin compared to baseline	3 months
Changes in the fecal microflora	Changes in the fecal microflora compared to baseline	3 months
QoL improvement	Improvement of the child's quality of life	3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Food Frequency Questionnaire	Evaluation of the child's eating habits	3 months

Collaborators and Investigators

• Sponsor: Noos S.r.l.
• Investigators: Principal Investigator: Attilio Boner, Professor, Policlinico G.B. Rossi, Head of the Pediatric Department

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2015
• Primary Completion (Actual): February 1, 2017
• Study Completion (Actual): February 1, 2018

Study Registration Dates

• First Submitted: October 24, 2016
• First Submitted That Met QC Criteria: October 24, 2016
• First Posted (Estimate): October 26, 2016

Study Record Updates

• Last Update Posted (Actual): March 22, 2023
• Last Update Submitted That Met QC Criteria: March 21, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: atopic dermatitis, probiotics, vitamin D3, L. reuteri
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic
• Other Study ID Numbers: ATOPIA_D3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO