Randomized Controlled Clinical Trial to Evaluate the Efficacy of Supplementation With L. Reuteri + Vit. D3 in Asthmatic Children
Overview
- Phase
- Phase 3
- Intervention
- Reuterin D3 drops
- Conditions
- Asthma
- Sponsor
- University of Campania "Luigi Vanvitelli"
- Enrollment
- 52
- Locations
- 1
- Primary Endpoint
- Reduction of allergic bronchial inflammation
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
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 .
Detailed Description
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).
Investigators
Prof. Michele Miraglia del Giudice
Prof.
University of Campania "Luigi Vanvitelli"
Eligibility Criteria
Inclusion Criteria
- •Patients aged between 6 and 14 years old, of both sexes
- •Diagnosis of mild / moderate persistent asthma (GINA step 2/3)
- •Allergy mite (Dermatophagoides farinae and pteronyssinus + + + / + + + +)
- •Levels of vitamin 25 (OH) D \<30 ng / ml
- •Signature of the informed consent of one parent or a legal representative
Exclusion Criteria
- •Cardiovascular disease or systemic
- •anatomical abnormalities
- •Other respiratory diseases
- •Taking probiotics and / or prebiotics in the previous 2 weeks
- •Taking vitamin D or systemic corticosteroids within 4 weeks
- •Participation in other clinical trials
Arms & Interventions
Reuterin D3 drops
Lactobacillus reuteri DSM 17938 (108 CFU) + Vitamin D3 (400 IU) 5 drops/day for 3 months (Reuterin D3 drops)
Intervention: Reuterin D3 drops
Placebo
The patients will receive 5 drops/day of placebo for 3 months
Intervention: Placebo
Outcomes
Primary Outcomes
Reduction of allergic bronchial inflammation
Time Frame: Up to 3 months
Reduction of a series of markers of bronchial inflammation: IL-2; IL-4; IL-10; IFN-γ.
Secondary Outcomes
- Improvement of asthma control by C-ACT(Up to 3 months)
- Improvement of asthma control by reduction of bronchodilator(Up to 3 months)
- Improvement of asthma control by improvement of FEV-1(Up to 3 months)