Ignite Creation Date:
2024-05-06 @ 9:16 AM
Last Modification Date:
2024-10-26 @ 12:12 PM
Study NCT ID:
NCT02945683
Status:
COMPLETED
Last Update Posted:
2023-03-22
First Post:
2016-10-24
Brief Title:
Effects of Lactobacillus Reuteri Plus Vitamin D3 in Children With Atopic Dermatitis
Sponsor:
Noos Srl
Organization:
Noos Srl
Study Overview
Official Title:
Randomized Controlled Trial to Evaluate the Beneficial Effects of a Probiotic Food Supplement in Children With Atopic Dermatitis
Status:
COMPLETED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None