RBR-7jsgnsh Study on the efficacy of Probiotics in the treatment of Asthma in children and adolescents

Date of registration: 12/19/2023 ^(mm/dd/yyyy)
Last approval date : 12/19/2023 ^(mm/dd/yyyy)

Study type:

Interventional

Scientific title:

Trial identification

• UTN code: U1111-1299-9643

• Public title:

  en

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

  pt-br

  Estudo sobre eficácia de Probióticos no tratamento da Asma em crianças e adolescentes

• Scientific acronym:

• Public acronym:
• Secondaries identifiers:
  • 65936122.9.0000.5440
    Issuing authority: Plataforma Brasil
  • 5.868.210
    Issuing authority: Comitê de Ética em Pesquisa da Universidade de São Paulo/Ribeirão Preto

Sponsors

• Primary sponsor: Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
• Secondary sponsor:
  • Institution: Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
• Supporting source:
  • Institution: Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

Health conditions

• Health conditions:

  en

  Asthma

  pt-br

  Asma

• General descriptors for health conditions:

• Specific descriptors:

  en

  C08.127.108 Asthma

  pt-br

  C08.127.108 Asma

  en

  J45.0 Predominantly allergic asthma

  pt-br

  J45.0 Asma predominantemente alérgica

Interventions

• Interventions:

  en

  This is a randomized controlled, double-blind clinical study. A total of 66 children and adolescents, aged between 6 and 20, who meet the eligibility criteria will be allocated probabilistically to one or other intervention group using a table of random numbers. Both the researchers who will evaluate the outcomes and the participants will not know which group each participant belongs to. Experimental group: 33 people with asthma will receive oral administration of combined probiotics twice a day for 1 year. Control group: 33 people with asthma will receive an oral placebo twice a day for one year. Patients will receive the probiotic mixture (Probiatop®) or placebo (hydrolyzed collagen) at a dose of 2 grams (2 sachets) once a day, without the prior knowledge of the researcher/evaluator. Patients will be instructed to dilute 2 sachets in 100mL of water and ingest them daily in the morning. The placebo should have the same color and consistency as the medication being studied. The treatment period will be 1 year, with follow-up for a further 6 months. During and after the study period, the patients will be followed up at the HCRP Allergy Outpatient Clinics.

  pt-br

  This is a randomized controlled, double-blind clinical study. A total of 66 children and adolescents, from 6 to 20 years old, who meet the eligibility criteria, will be allocated probabilistically to one or other intervention group using a table of random numbers. Both the researchers who will evaluate the outcomes and the participants will not know which group each participant belongs to. Experimental group: 33 people with asthma will receive oral administration of combined probiotics twice a day for 1 year. Control group: 33 people with asthma will receive an oral placebo twice a day for one year. Patients will receive the probiotic mixture (Probiatop®) or placebo (hydrolyzed collagen) at a dose of 2 grams (2 sachets) once a day, without the prior knowledge of the researcher/evaluator. Patients will be instructed to dilute 2 sachets in 100mL of water and ingest them daily in the morning. The placebo should have the same color and consistency as the medication being studied. The treatment period will be 1 year, with follow-up for a further 6 months. During and after the study period, the patients will continue to be followed up at the HCRP Allergy Ambulatories.

• Descriptors:

  en

  G07.203.300.456.500 Probiotics

  pt-br

  G07.203.300.456.500 Probióticos

Recruitment

• Study status: Recruiting
• Countries
  • Brazil
• Date first enrollment: 04/24/2023 ^(mm/dd/yyyy)

• Target sample size:	Gender:	Minimum age:	Maximum age:
  66	-	6 Y	20 Y

• Inclusion criteria:

  en

  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.

  pt-br

  Crianças e adolescentes entre 6 e 20 anos de idade; Diagnóstico de asma persistente leve, moderada ou grave, controlada ou não controlada; Sensibilização a pelo menos, 1 aeroalérgeno (prick-teste ou IgE específica) e/ou IgE total ≥ 100 kU/L.

• Exclusion criteria:

  en

  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.

  pt-br

  Não concordância em participar da criança/adolescente ou dos pais/responsáveis; Alergia ou reação adversa grave atribuível à administração da mistura de probióticos ou placebo; Falha na administração correta do medicamento; Não aderência ao tratamento (ou seja, não apresentar uso regular, conforme a prescrição) por, no mínimo, um mês contínuo; Falta de comparecimento em mais de 50% das avaliações (clínicas e/ou laboratoriais) que serão realizadas durante o estudo; História prévia conhecida de alergia à mistura de probióticos; Uso de corticosteroides orais, imunossupressores ou imunobiológicos dentro de 30 dias antes do recrutamento; Outras pneumopatias crônicas.

Study type

• Study design:

• Expanded access program	Purpose	Intervention assignment	Number of arms	Masking type	Allocation	Study phase
  1	Treatment	Parallel	2	Double-blind	Randomized-controlled	3

Outcomes

• Primary outcomes:

  en

  Favorable clinical response in research participants with asthma, as well as an increase in cytokines responsible for tolerance and a reduction in inflammatory markers.

  pt-br

  Resposta clínica favorável nos participantes da pesquisa com asma, assim como um aumento das citocinas responsáveis pela tolerância e redução dos marcadores inflamatórios.

• Secondary outcomes:

  en

  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.

  pt-br

  Melhora no controle de outras doenças alérgicas, como rinite alérgica e dermatite atópica, além da melhora da qualidade de vida do participante da pesquisa.

Contacts

• Public contact
  • Full name: Daniel Messias Martins Alves Neiva
  • • Address: R. Ten. Catão Roxo, 3900 - Vila Monte Alegre
    • City: Ribeirão Preto / Brazil
    • Zip code: 14015-010
  • Phone: +5531997648960
  • Email: danielmessias2@hotmail.com.br
  • Affiliation: Universidade de São Paulo - Ribeirão Preto
   
• Scientific contact
  • Full name: Daniel Messias Martins Alves Neiva
  • • Address: R. Ten. Catão Roxo, 3900 - Vila Monte Alegre
    • City: Ribeirão Preto / Brazil
    • Zip code: 14015-010
  • Phone: +5531997648960
  • Email: danielmessias2@hotmail.com.br
  • Affiliation: Universidade de São Paulo - Ribeirão Preto
   
• Site contact
  • Full name: Daniel Messias Martins Alves Neiva
  • • Address: R. Ten. Catão Roxo, 3900 - Vila Monte Alegre
    • City: Ribeirão Preto / Brazil
    • Zip code: 14015-010
  • Phone: +5531997648960
  • Email: danielmessias2@hotmail.com.br
  • Affiliation: Universidade de São Paulo - Ribeirão Preto
   

Additional links:

• Download in ICTRP format