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Trial record 22 of 154 for:    Dermatitis, Atopic, 8

Trial on Effectiveness Combined Probiotics in Atopic Dermatitis in Children

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ClinicalTrials.gov Identifier: NCT02519556
Recruitment Status : Completed
First Posted : August 11, 2015
Last Update Posted : May 2, 2017
Sponsor:
Collaborator:
University of Sao Paulo
Information provided by (Responsible Party):
Fabio Carmona, 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]).


Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: Probiatop Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Randomized, Double Blind, Controlled Trial on Effectiveness Combined Probiotics in the Treatment of Atopic Dermatitis in Children up to 6 Months
Actual Study Start Date : August 2015
Actual Primary Completion Date : August 2016
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Experimental: 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
Drug: Probiatop
Dilute one sachet in 100ml of water and take it in every morning, once a day for 6 months.
Other Name: Probiotics

Placebo Comparator: Placebo
Placebo of Maltodextrin in sachet
Drug: Placebo
1 sachet, once a day for 6 months. Dilute one sachet in 100ml of water and take it in every morning.
Other Name: Maltodextrin




Primary Outcome Measures :
  1. SCORAD [ Time Frame: 1 year ]
    Change from baseline in SCORAD every 3 months for 1 year


Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   6 Months to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02519556


Locations
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Brazil
Hospital das Clínicas FMRP-USP
Ribeirão Preto, São Paulo, Brazil, 14048-900
Sponsors and Collaborators
Casa Espirita Terra de Ismael
University of Sao Paulo
Investigators
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Principal Investigator: Paula A Andrade, MD HCFMRP-USP
Study Director: Persio Roxo-Junior, MD, PhD HCFMRP-USP
Study Chair: Vanessa Carregaro, PhD USP-RP
Study Chair: Jorgete Maria e Silva, MD, Msc HCFMRP-USP
Study Chair: Luciana Roberti FMRP-USP
Study Chair: Laís Sacramento, Msc USP-RP

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Responsible Party: Fabio Carmona, University of Sao Paulo, Casa Espirita Terra de Ismael
ClinicalTrials.gov Identifier: NCT02519556     History of Changes
Other Study ID Numbers: ProbioticsAD2015
First Posted: August 11, 2015    Key Record Dates
Last Update Posted: May 2, 2017
Last Verified: April 2017
Keywords provided by Fabio Carmona, Casa Espirita Terra de Ismael:
Probiotics
Inflammation
Awareness
Immune tolerance
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases