Allergic Rhinitis Unspecified Allergy
Conditions
Interventions
This is a randomized, controlled, two-arm, double-blind clinical trial. The study will include 72 children aged 6 to 12 years with allergic rhinitis who mett the eligibility criteria. Participants wil
Sponsors
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da USP
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da USP
Eligibility
Age
6 Years to 12 Years
Inclusion criteria
Inclusion criteria: Children aged 6 to 12 years; with a clinical diagnosis of allergic rhinitis according to guidelines for allergic rhinitis by trained professionals; sensitization of at least 1 aeroallergen (immediate-read skin test or specific IgE) and/or IgE above 100
Exclusion criteria
Exclusion criteria: Request from parents or guardians; Presence of a diagnosis or clinical signs suggestive of inborn errors of immunity; Allergy or severe adverse reaction at the start of the intervention; Non-adherence to treatment (failure to use the treatment regularly as prescribed) for at least one continuous month; Failure to attend more than 50% of the evaluations (clinical and/or laboratory) that will be carried out during the research
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the clinical efficacy of a mixture of probiotics (Lactobacillus rhamnosus, Lactobacillus acidophilus, Bifidobacterium lactis and Lactobacillus paracasei) in children with allergic rhinitis, using the TNSS (total nasal symptom score). Improvement of least 2 points in this score in the intervention group;To evaluate the clinical efficacy of a mixture of probiotics (Lactobacillus rhamnosus, Lactobacillus acidophilus, Bifidobacterium lactis and Lactobacillus paracasei) in children with AR, using the TNSS score. | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate the effects of the probiotic mixture: Impact on quality of life using the PQRLQ questionnaire; Frequency of nasal corticosteroid and anti-H1 use; Occurrence/frequency of upper airway infections; Inflammatory and tolerogenic cytokines (IL1ß, IFN-?, IL4, IL5, IL6, IL10, IL13, IL17, TGF-ß and TNF-a); Sensitization: prick test and total serum IgE. Administration of the mixture of probiotic strains leads to a favorable clinical response in patients with allergic rhinitis, as well as playing a relevant role in reducing inflammation and inducing tolerance, reducing the intensity of rhinitis symptoms, consequently improving the quality of life of these patients | — |
Countries
BR
Contacts
Public ContactMarina Benevides Pinheiro Cavalcante
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da USP
Outcome results
None listed