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
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
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
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
1 sachet, once a day for 6 months. Dilute one sachet in 100ml of water and take it in every morning.
Other Name: Maltodextrin
- SCORAD [ Time Frame: 1 year ]Change from baseline in SCORAD every 3 months for 1 year
- Skin prick test (immediate awareness) [ Time Frame: 1 year ]
- Inflammation composite [ Time Frame: 1 year ]ɣ - IFN, IL-1β, IL -4 , IL -6, IL-8 and tumor necrosis factor
- Immune tolerance composite [ Time Frame: 1 year ]IL-10, TGF - β and IL -17
- Total serum IgE [ Time Frame: 1 year ]
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
|Hospital das Clínicas FMRP-USP|
|Ribeirão Preto, São Paulo, Brazil, 14048-900|
|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|