Probiotics in Paediatric Asthma Management (ProPAM)

Probiotical

Status: Completed

Conditions: Asthma in Children

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Bifiasthm

Study type: Interventional

Funder types: Industry

Identifiers

NCT04289441

SCCE n.41486

Details and patient eligibility

About

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.

Full 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.

Enrollment: 46 patients

Sex: All

Ages: 1 to 14 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

46 participants in 2 patient groups, including a placebo group

probiotic treatment

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Bifiasthm

Placebo treatment

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo