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Completed

NCT Number: NCT02519556

Trial on Effectiveness Combined Probiotics in Atopic Dermatitis in Children

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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Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

6 month–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital das Clínicas FMRP-USP

Ribeirão Preto, São Paulo, 14048-900, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Probiatop

Drug

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

Other names: Probiotics

Placebo

Drug

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

Other names: Maltodextrin

Primary outcomes

  1. SCORAD

    Time frame: 1 year

    Change from baseline in SCORAD every 3 months for 1 year

Secondary outcomes

  1. Skin prick test (immediate awareness)

    Time frame: 1 year

  2. Inflammation composite

    Time frame: 1 year

    ɣ - IFN, IL-1β, IL -4 , IL -6, IL-8 and tumor necrosis factor

  3. Immune tolerance composite

    Time frame: 1 year

    IL-10, TGF - β and IL -17

  4. Total serum IgE

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Casa Espirita Terra de Ismael

Other

Collaborators

  • University of Sao Paulo

Registry information

Official study title

Randomized, Double Blind, Controlled Trial on Effectiveness Combined Probiotics in the Treatment of Atopic Dermatitis in Children

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Aug 11, 2015
Registry last updated
Jan 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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