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Trial on Effectiveness Combined Probiotics in Atopic Dermatitis in Children

NCT02519556 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2021-01-28

No results posted yet for this study

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

Interventions

DRUG

Probiatop

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

DRUG

Placebo

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

Sponsors & Collaborators

  • University of Sao Paulo

    collaborator OTHER

  • Casa Espirita Terra de Ismael

    lead OTHER

Principal Investigators

  • Paula A Andrade, MD · HCFMRP-USP

  • Persio Roxo-Junior, MD, PhD · HCFMRP-USP

  • Vanessa Carregaro, PhD · USP-RP

  • Jorgete Maria e Silva, MD, Msc · HCFMRP-USP

  • Luciana Roberti · FMRP-USP

  • Laís Sacramento, Msc · USP-RP

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2016-08-31
Completion
2016-08-31

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02519556 on ClinicalTrials.gov