Probiotics in Paediatric Asthma Management

Asthma in Children Clinical Trial

— ProPAM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04289441
• Other study ID #: SCCE n.41486
• Status: Completed
• Phase: N/A
• Start date: April 21, 2017
• Est. completion date: November 25, 2019

Study information

• Verified date: January 2023
• Source: Probiotical S.p.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: November 25, 2019
• Est. primary completion date: April 21, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 14 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Asthma in Children

Intervention

Dietary Supplement:
• Bifiasthm
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
Placebo

Locations

Country	Name	City	State
Italy	Primary Care Ambulatory	Pozzuoli	Naples

Sponsors (1)

Lead Sponsor	Collaborator
Probiotical S.p.A.

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in Asthma episodes	Reduction in the frequency and severity of asthma crises, the evaluation is performed using Guidelines for management of Asthma, Italian Society of Pediatricians	12 months
Primary	Reduction in wheezing	Reduction in the frequency of wheezing episodes, numerical evaluation.	12 months
Secondary	Reduction of adminstrated drug quantity	Reduction in the administered drug quantity for asthma crisis treatment	12 months
Secondary	Reduction in treatment time	use of short-term treatments	12 months