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

Phase 3

Completed

• Conditions: Asthma
• Interventions: Drug: Reuterin D3 drops; Other: Placebo

• Registration Number: NCT02734446
• Lead Sponsor: University of Campania "Luigi Vanvitelli"

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).

Study Timeline

• Study Start: 2014-04
• Primary Completion: 2015-02
• Study Completion: 2016-03
• Study First Submitted: 2016-03-18
• Status Verified: 2016-04
• Study First Submitted QC: 2016-04-05
• Last Update Submitted: 2016-04-05
• Study First Posted: 2016-04-12
• Last Update Posted: 2016-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Reuterin D3 drops	Reuterin D3 drops	Lactobacillus reuteri DSM 17938 (108 CFU) + Vitamin D3 (400 IU) 5 drops/day for 3 months (Reuterin D3 drops)
Placebo	Placebo	The patients will receive 5 drops/day of placebo for 3 months

Primary Outcome Measures

Name	Time	Method
Reduction of allergic bronchial inflammation	Up to 3 months	Reduction of a series of markers of bronchial inflammation: IL-2; IL-4; IL-10; IFN-γ.

Secondary Outcome Measures

Name	Time	Method
Improvement of asthma control by C-ACT	Up to 3 months	Improvement in asthma control assessed by: C-ACT (Scores \> 19)
Improvement of asthma control by reduction of bronchodilator	Up to 3 months	Improvement in asthma control assessed by: Reduction use of bronchodilator
Improvement of asthma control by improvement of FEV-1	Up to 3 months	Improvement in asthma control assessed by: Improvement of Forced Expiratory Volume in 1 second (FEV-1)

Trial Locations

Locations (1)

Second University of Naples; 🇮🇹 Naples, Italy