Trial on Effectiveness Combined Probiotics in Atopic Dermatitis in Children

Phase 4

Completed

• Conditions: Atopic Dermatitis
• Interventions: Drug: Placebo; Drug: Probiatop

• Registration Number: NCT02519556
• Lead Sponsor: Casa Espirita Terra de Ismael

Brief Summary

Atopic dermatitis (AD) is an immune disorder, characterized by chronic skin inflammation or relapsing, whose prevalence is increasing worldwide. Its exact etiology remains unknown. The hypothesis that an appropriate early stimulation of the intestinal flora contributes to the establishment of the immune system balance has led to the use of probiotics in the prevention and treatment of AD in several clinical and experimental studies.

Therefore, the objectives of this study will evaluate the clinical efficacy of the mixture of probiotics (Lactobacillus and Bifidobacterium) in children with AD through the SCORAD (scoring atopic dermatitis) and to evaluate the effects of this medication in the following laboratory parameters: skin prick test, total serum immunoglobulin E (IgE), inflammation composite (interferon gamma \[ɣ - IFN\], interleukins \[IL1-β, IL-4, IL-6, IL-8\] and tumor necrosis factor alpha) and immune tolerance composite (IL-10, IL-17 and transforming growth factor beta \[TGF - β\]).

Detailed Description

Not available

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2015-08-04
• Study First Submitted QC: 2015-08-06
• Study First Posted: 2015-08-11
• Primary Completion: 2016-08
• Study Completion: 2016-08
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-26
• Last Update Posted: 2021-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Clinical diagnosis of Atopic Dermatitis
• Children over 6 months.
• Teens lower than 19 years

No inclusion /

Exclusion Criteria

• Diagnostic presence or clinical signs suggesting acute or chronic skin diseases, as well as pertinent to the study, which may affect the outcome of the research.
• Being in use of drugs that can affect systemically in the course of the disease, such as systemic corticosteroids and immunosuppressants, for at least 30 days.
• Allergy or severe adverse reactions attributable to the administration of the probiotic.
• Non adherence to treatment (ie not present regular use, as prescribed) for at least one continuous month.
• Lack of attendance by more than 50% of ratings (clinical and/or laboratory) to be held during the search.
• Patient's request (or responsible's request)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo of Maltodextrin in sachet
Probiatop	Probiatop	Probiotic comprising the mixture of strains: Lactobacillus rhamnosus, Lactobacillus acidophilus, Lactobacillus paracasei and Bifidobacterium lactis, at a dose of 1 gram sachet, once a day for 6 months

Primary Outcome Measures

Name	Time	Method
SCORAD	1 year	Change from baseline in SCORAD every 3 months for 1 year

Secondary Outcome Measures

Name	Time	Method
Inflammation composite	1 year	ɣ - IFN, IL-1β, IL -4 , IL -6, IL-8 and tumor necrosis factor
Immune tolerance composite	1 year	IL-10, TGF - β and IL -17
Total serum IgE	1 year
Skin prick test (immediate awareness)	1 year

Trial Locations

Locations (1)

Hospital das Clínicas FMRP-USP; 🇧🇷 Ribeirão Preto, São Paulo, Brazil