Probiotics in Paediatric Asthma Management

Not Applicable

Completed

• Conditions: Asthma in Children
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Bifiasthm

• Registration Number: NCT04289441
• Lead Sponsor: Probiotical S.p.A.

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2017-04-21
• Primary Completion: 2019-04-21
• Study Completion: 2019-11-25
• Study First Submitted: 2020-01-23
• Study First Submitted QC: 2020-02-27
• Study First Posted: 2020-02-28
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-25
• Last Update Posted: 2023-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo treatment	Placebo	For the first 8 weeks was administered 1 sachet in the morning and 1 in the evening, for the last 8 weeks was administered 1 sachet per day Maltodextrin and silicon dioxide
probiotic treatment	Bifiasthm	For the first 8 weeks was administered 1 sachet in the morning and 1 in the evening, for the last 8 weeks was administered 1 sachet per day Lactobacillus salivarius LS01 (DSM 22775): 10\^9 CFU Bifidobacterium breve B632 (DSM 24706): 10\^9 CFU Maltodextrin and silicon dioxide

Primary Outcome Measures

Name	Time	Method
Reduction in Asthma episodes	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
Reduction in wheezing	12 months	Reduction in the frequency of wheezing episodes, numerical evaluation.

Secondary Outcome Measures

Name	Time	Method
Reduction of adminstrated drug quantity	12 months	Reduction in the administered drug quantity for asthma crisis treatment
Reduction in treatment time	12 months	use of short-term treatments

Trial Locations

Locations (1)

Primary Care Ambulatory; 🇮🇹 Pozzuoli, Naples, Italy