NCT02734446

To Evaluate the Efficacy of Supplementation With L. Reuteri + Vit. D3 in Asthmatic Children

Randomized Controlled Clinical Trial to Evaluate the Efficacy of Supplementation With L. Reuteri + Vit. D3 in Asthmatic Children

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: University of Campania Luigi Vanvitelli · Academic / Other
• Sex: All
• Age: 6 Years – 14 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	Reuterin D3 drops	5 drops/day for 3 months
OTHER	Placebo	5 drops/day for 3 months

Timeline

• Start date: 2014-04-01
• Primary completion: 2015-02-01
• Completion: 2016-03-01
• First posted: 2016-04-12
• Last updated: 2016-04-12

Locations

1 site across 1 country: Italy