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

Atopic Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02945683
• Other study ID #: ATOPIA_D3
• Status: Completed
• Phase: N/A
• Start date: February 2015
• Est. completion date: February 2018

Study information

• Verified date: March 2023
• Source: Noos S.r.l.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: February 2018
• Est. primary completion date: February 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year to 4 Years

Eligibility

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

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

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
sunflower oil, medium chain triglycerides, silicon dioxide

Locations

Country	Name	City	State
Italy	Policlinico G.B. Rossi	Verona

Sponsors (1)

Lead Sponsor	Collaborator
Noos S.r.l.

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Food Frequency Questionnaire	Evaluation of the child's eating habits	3 months
Primary	SCORAD improvement	Improvement of the SCORAD compared to baseline	3 months
Secondary	Vitamin D levels increase	Increase of the levels of Vit. D compared to baseline	3 months
Secondary	LL-37 levels increase	Increase of the levels of cathelicidin compared to baseline	3 months
Secondary	Changes in the fecal microflora	Changes in the fecal microflora compared to baseline	3 months
Secondary	QoL improvement	Improvement of the child's quality of life	3 months