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The purpose of this project is to evaluate in a randomized clinical trial, double-blind, controlled, the effects of a dietary supplement containing Lactobacillus reuteri DSM 17938 and vitamin D3 in reducing bronchial inflammation and improve asthma control in patients in children with mild / moderate persistent asthma .
To evaluate if the supplementation for three months with Lactobacillus reuteri DSM 17938 (108 CFU) + Vitamin D3 (400 IU) result in a reduction of the degree of allergic bronchial inflammation, measured with the Fractional exhaled nitric oxide (FeNO) and with a series of markers of bronchial inflammation (measured at 'beginning and at the end of the treatment on exhaled condensate): Interleukin 2(IL-2); Interleukin 4 (IL-4); Interleukin 10(IL-10); Interferon γ (IFN-γ).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reuterin D3 drops | Active Comparator | Lactobacillus reuteri DSM 17938 (108 CFU) + Vitamin D3 (400 IU) 5 drops/day for 3 months (Reuterin D3 drops) |
|
| Placebo | Placebo Comparator | The patients will receive 5 drops/day of placebo for 3 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reuterin D3 drops | Drug | 5 drops/day for 3 months |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of allergic bronchial inflammation | Reduction of FeNO values | Up to 3 months |
| Reduction of allergic bronchial inflammation | Reduction of a series of markers of bronchial inflammation: IL-2; IL-4; IL-10; IFN-γ. | Up to 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of asthma control by C-ACT | Improvement in asthma control assessed by: C-ACT (Scores > 19) | Up to 3 months |
| Improvement of asthma control by reduction of bronchodilator | Improvement in asthma control assessed by: Reduction use of bronchodilator |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Second University of Naples | Naples | Italy | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27720582 | Derived | Miraglia Del Giudice M, Maiello N, Allegorico A, Iavarazzo L, Capasso M, Capristo C, Ciprandi G. Lactobacillus reuteri DSM 17938 plus vitamin D3 as ancillary treatment in allergic children with asthma. Ann Allergy Asthma Immunol. 2016 Dec;117(6):710-712. doi: 10.1016/j.anai.2016.09.004. Epub 2016 Oct 6. No abstract available. |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| Placebo | Other | 5 drops/day for 3 months |
|
| Up to 3 months |
| Improvement of asthma control by improvement of FEV-1 | Improvement in asthma control assessed by: Improvement of Forced Expiratory Volume in 1 second (FEV-1) | Up to 3 months |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |