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Study on the efficacy of Probiotics in the treatment of Asthma in children and adolescents

Phase 3
Recruiting
Conditions
Asthma
Registration Number
RBR-7jsgnsh
Lead Sponsor
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Not specified
Target Recruitment
Not specified
Inclusion Criteria

Children and adolescents between 6 and 20 years of age; Diagnosis of mild, moderate or severe persistent asthma, controlled or uncontrolled; Sensitization to at least 1 aeroallergen (prick test or specific IgE) and/or total IgE = 100 kU/L.

Exclusion Criteria

Non-agreement to participate by the child/adolescent or parent/guardian; Allergy or serious adverse reaction attributable to the administration of the probiotic mixture or placebo; Failure to administer the medication correctly; Non-adherence to treatment (i.e. not using it regularly, as prescribed) for at least one continuous month; Failure to attend more than 50% of the assessments (clinical and/or laboratory) that will be carried out during the study; Previous known history of allergy to the probiotic mixture; Use of oral corticosteroids, immunosuppressants or immunobiologicals within 30 days prior to recruitment; Other chronic pneumopathies.

Study & Design

Study Type
Intervention
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Favorable clinical response in research participants with asthma, as well as an increase in cytokines responsible for tolerance and a reduction in inflammatory markers.
Secondary Outcome Measures
NameTimeMethod
It is hoped to improve the control of other allergic diseases, such as allergic rhinitis and atopic dermatitis, as well as improving the quality of life of the research participant.
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