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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| probiotic treatment | Active Comparator | 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 |
|
| Placebo treatment | Placebo Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bifiasthm | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Reduction in wheezing | Reduction in the frequency of wheezing episodes, numerical evaluation. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of adminstrated drug quantity | Reduction in the administered drug quantity for asthma crisis treatment | 12 months |
| Reduction in treatment time | use of short-term treatments |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Primary Care Ambulatory | Pozzuoli | Naples | 80078 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35487387 | Derived | 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. |
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Randomized controlled double-blind trial
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| Placebo | Dietary Supplement | Placebo |
|
| 12 months |