Trial on Effectiveness Combined Probiotics in Atopic Dermatitis in Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2016-08-31

Brief Summary

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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 \[TGF - β\]).

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Detailed Description

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Conditions

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Atopic Dermatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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

Group Type EXPERIMENTAL

Probiatop

Intervention Type DRUG

Dilute one sachet in 100ml of water and take it in every morning, once a day for 6 months.

Placebo

Placebo of Maltodextrin in sachet

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

1 sachet, once a day for 6 months. Dilute one sachet in 100ml of water and take it in every morning.

Interventions

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Probiatop

Dilute one sachet in 100ml of water and take it in every morning, once a day for 6 months.

Intervention Type DRUG

Placebo

1 sachet, once a day for 6 months. Dilute one sachet in 100ml of water and take it in every morning.

Intervention Type DRUG

Other Intervention Names

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Probiotics Maltodextrin

Eligibility Criteria

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Inclusion Criteria

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

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)

Minimum Eligible Age

6 Months

Maximum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No