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Completed

NCT Number: NCT04289441

Probiotics in Paediatric Asthma Management

Randomized controlled double-blind trial in a child population with allergic asthma and recurring wheezing, undergoing probiotic treatment with Bifiasthm with the aim of assessing the reduction in asthma attacks.

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Key information

Conditions

Asthma in Children

Age range

1 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Primary Care Ambulatory

Pozzuoli, Naples, 80078, Italy

About this study

Allergic disorders have dramatically increased in prevalence over the past decade, particularly in developed countries, and primary prevention of allergic disease has proved an elusive goal. There is increasing evidence that the airway microbiome influences the development of wheezing and childhood asthma. Probiotics are increasingly considered as a promising treatment for the correction of dysbiosis, reduction of systemic inflammation, and modulation of allergic diseases. The aim of this study is, therefore, to evaluate the efficacy of Bifidobacterium breve B632 (DSM 24706) and Lactobacillus salivarius LS01 (DSM 22775) in the prevention of asthmatic allergies in human subjects.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The study will include all children aged 6 to 14, with slight and moderate persistent asthma according to GINA 2015 criteria (asthma classification did not change in GINA 2015 and 2016 guidelines), whether or not showing positive skin allergometric tests, as well as all children aged 2 yrs, 364 days to 5 years, 364 days, with recurring wheezing, whether or not diagnosed with asthma (positive and/or negative prick).

Exclusion criteria

  • Severe persistent asthma
  • Known congenital or acquired immunodeficiencies
  • Cystic fibrosis
  • Chronic pulmonary diseases (bronchodysplasia)
  • Age < 1 yr, 364d and 14 yrs

Treatment and study plan

Bifiasthm

Dietary Supplement

Subjects will be instructed to take an active or placebo sachet twice daily for eight weeks, and subsequent intake of one dose daily for a further eight weeks.

Placebo

Dietary Supplement

Placebo

Primary outcomes

  1. Reduction in Asthma episodes

    Time frame: 12 months

    Reduction in the frequency and severity of asthma crises, the evaluation is performed using Guidelines for management of Asthma, Italian Society of Pediatricians

  2. Reduction in wheezing

    Time frame: 12 months

    Reduction in the frequency of wheezing episodes, numerical evaluation.

Secondary outcomes

  1. Reduction of adminstrated drug quantity

    Time frame: 12 months

    Reduction in the administered drug quantity for asthma crisis treatment

  2. Reduction in treatment time

    Time frame: 12 months

    use of short-term treatments

Sponsors and collaborators

Lead sponsor

Probiotical S.p.A.

Industry

Registry information

Official study title

"Randomized Controlled Double-blind Trial With Lactobacillus Salivarius LS01 (DSM 22775) and Bifidobacterium Breve B632 (DSM 24706) for Paediatric Asthma Management"

Acronym: ProPAM

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Feb 28, 2020
Registry last updated
Jan 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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