Trial on Effectiveness Combined Probiotics in Atopic Dermatitis in Children

NCT02519556 | Completed Phase 4 DMC

• 1 other identifier: ProbioticsAD2015
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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 \[TGF - β\]).

Conditions

Atopic Dermatitis

Keywords

Probiotics; Inflammation; Awareness; Immune tolerance

Outcome Measures

Primary Outcomes (1)

• SCORAD

  Change from baseline in SCORAD every 3 months for 1 year

  1 year

Secondary Outcomes (4)

• Skin prick test (immediate awareness)

  1 year

• Inflammation composite

  1 year

• Immune tolerance composite

  1 year

• Total serum IgE

  1 year

Study Arms (2)

Probiatop

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

Placebo of Maltodextrin in sachet

Drug: Placebo

Interventions

Probiatop DRUG

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

Also known as: Probiotics

Probiatop

Placebo DRUG

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

Also known as: Maltodextrin

Placebo

Eligibility Criteria

• Age: 6 Months - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Casa Espirita Terra de Ismael: lead
• University of Sao Paulo: collaborator

Study Sites (1)

Hospital das Clínicas FMRP-USP

Ribeirão Preto, São Paulo, 14048-900, Brazil

Location

MeSH Terms

Conditions

Dermatitis, Atopic; Inflammation

Interventions

Probiotics; maltodextrin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Paula A Andrade, MD

  HCFMRP-USP

  PRINCIPAL INVESTIGATOR

• Persio Roxo-Junior, MD, PhD

  HCFMRP-USP

  STUDY DIRECTOR

• 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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: University of Sao Paulo

Study Record Dates

• First Submitted: August 4, 2015
• First Posted: August 11, 2015
• Study Start: August 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: January 28, 2021

Record last verified: 2021-01

Locations

BR (1)