Probiotics in Paediatric Asthma Management

NCT ID: NCT04289441

Last Updated: 2023-01-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-21
• Study Completion Date: 2019-11-25

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.

Conditions

Asthma in Children

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

probiotic treatment

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

Group Type: ACTIVE_COMPARATOR

Bifiasthm

Intervention Type: 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 treatment

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Probiotical S.p.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Primary Care Ambulatory

Pozzuoli, Naples, Italy

Countries

Italy

References

Ciprandi G, Schiavetti I, Cioffi L, Pane M, Drago L. The Probiotics in Pediatric Asthma Management (PROPAM) study: A Post Hoc analysis in allergic children. Ann Allergy Asthma Immunol. 2022 Jul;129(1):111-113. doi: 10.1016/j.anai.2022.04.026. Epub 2022 Apr 26. No abstract available.

Reference Type: DERIVED

PMID: 35487387 (View on PubMed)

Other Identifiers

SCCE n.41486

Identifier Type: -

Identifier Source: org_study_id