Trial on Effectiveness Combined Probiotics in Atopic Dermatitis in Children

Atopic Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02519556
• Other study ID #: ProbioticsAD2015
• Status: Completed
• Phase: Phase 4
• Start date: August 2015
• Est. completion date: August 2016

Study information

• Verified date: January 2021
• Source: Casa Espirita Terra de Ismael
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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]).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 19 Years

Eligibility

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)

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

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

Locations

Country	Name	City	State
Brazil	Hospital das Clínicas FMRP-USP	Ribeirão Preto	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
Casa Espirita Terra de Ismael	University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SCORAD	Change from baseline in SCORAD every 3 months for 1 year	1 year
Secondary	Skin prick test (immediate awareness)		1 year
Secondary	Inflammation composite	? - IFN, IL-1ß, IL -4 , IL -6, IL-8 and tumor necrosis factor	1 year
Secondary	Immune tolerance composite	IL-10, TGF - ß and IL -17	1 year
Secondary	Total serum IgE		1 year