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Trial on Effectiveness Combined Probiotics in Atopic Dermatitis in Children

Primary Purpose

Atopic Dermatitis

Status

Completed

Phase

Phase 4

Locations

Brazil

Study Type

Interventional

Intervention

Probiatop

Placebo

About this trial

This is an interventional treatment trial for Atopic Dermatitis focused on measuring Probiotics, Inflammation, Awareness, Immune tolerance

Eligibility Criteria

6 Months - 19 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Hospital das Clínicas FMRP-USP

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Probiatop

Placebo

Arm Description

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

Placebo of Maltodextrin in sachet

Outcomes

Primary Outcome Measures

SCORAD

Change from baseline in SCORAD every 3 months for 1 year

Secondary Outcome Measures

Skin prick test (immediate awareness)

Inflammation composite

ɣ - IFN, IL-1β, IL -4 , IL -6, IL-8 and tumor necrosis factor

Immune tolerance composite

IL-10, TGF - β and IL -17

Total serum IgE

Full Information

NCT ID

NCT02519556

First Posted

August 4, 2015

Last Updated

January 26, 2021

Sponsor

Casa Espirita Terra de Ismael

Collaborators

University of Sao Paulo

1. Study Identification

Unique Protocol Identification Number

NCT02519556

Brief Title

Trial on Effectiveness Combined Probiotics in Atopic Dermatitis in Children

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Completed

Study Start Date

August 2015 (Actual)

Primary Completion Date

August 2016 (Actual)

Study Completion Date

August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Casa Espirita Terra de Ismael

Collaborators

University of Sao Paulo

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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]).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atopic Dermatitis

Keywords

Probiotics, Inflammation, Awareness, Immune tolerance

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Probiatop

Arm Type

Experimental

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo of Maltodextrin in sachet

Intervention Type

Drug

Intervention Name(s)

Probiatop

Other Intervention Name(s)

Probiotics

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

Maltodextrin

Intervention Description

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

Primary Outcome Measure Information:

Title

SCORAD

Description

Change from baseline in SCORAD every 3 months for 1 year

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Skin prick test (immediate awareness)

Time Frame

1 year

Title

Inflammation composite

Description

ɣ - IFN, IL-1β, IL -4 , IL -6, IL-8 and tumor necrosis factor

Time Frame

1 year

Title

Immune tolerance composite

Description

IL-10, TGF - β and IL -17

Time Frame

1 year

Title

Total serum IgE

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Months

Maximum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Overall Study Officials: