Clinical trial NCT02519556: Trial on Effectiveness Combined Probiotics in Atopic Dermatitis in Children
Official title: Randomized, Double Blind, Controlled Trial on Effectiveness Combined Probiotics in the Treatment of Atopic Dermatitis in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Atopic Dermatitis
Keywords: Probiotics
Inflammation
Awareness
Immune tolerance
Lead sponsor: Casa Espirita Terra de Ismael
Sponsor class: OTHER
Collaborators: name: University of Sao Paulo
First posted: 2015-08-11
Enrollment: 60
Sex: ALL
Minimum age (years): 6
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 \[TGF - β\]).


Eligibility criteria: 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)

Primary outcomes:
measure: SCORAD
timeFrame: 1 year
Secondary outcomes:
measure: Skin prick test (immediate awareness)
timeFrame: 1 year
measure: Inflammation composite
timeFrame: 1 year
measure: Immune tolerance composite
timeFrame: 1 year
measure: Total serum IgE
timeFrame: 1 year
Other outcomes:
Locations:
city: Ribeirão Preto
country: Brazil
facility: Hospital das Clínicas FMRP-USP
state: São Paulo
Study officials:
affiliation: HCFMRP-USP
name: Paula A Andrade, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: HCFMRP-USP
name: Persio Roxo-Junior, MD, PhD
role: STUDY_DIRECTOR
affiliation: USP-RP
name: Vanessa Carregaro, PhD
role: STUDY_CHAIR
affiliation: HCFMRP-USP
name: Jorgete Maria e Silva, MD, Msc
role: STUDY_CHAIR
affiliation: FMRP-USP
name: Luciana Roberti
role: STUDY_CHAIR
affiliation: USP-RP
name: Laís Sacramento, Msc
role: STUDY_CHAIR
References: