Trials / Completed
CompletedNCT04289441
Probiotics in Paediatric Asthma Management
"Randomized Controlled Double-blind Trial With Lactobacillus Salivarius LS01 (DSM 22775) and Bifidobacterium Breve B632 (DSM 24706) for Paediatric Asthma Management"
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 46 (actual)
- Sponsor
- Probiotical S.p.A. · Industry
- Sex
- All
- Age
- 1 Year – 14 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
| DIETARY_SUPPLEMENT | Placebo | Placebo |
Timeline
- Start date
- 2017-04-21
- Primary completion
- 2019-04-21
- Completion
- 2019-11-25
- First posted
- 2020-02-28
- Last updated
- 2023-01-27
Locations
1 site across 1 country: Italy
Source: ClinicalTrials.gov record NCT04289441. Inclusion in this directory is not an endorsement.