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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02734446
• Other study ID #: RTN_D3
• Status: Completed
• Phase: Phase 3
• First received: March 18, 2016
• Last updated: April 5, 2016
• Start date: April 2014
• Est. completion date: March 2016

Study information

• Verified date: April 2016
• Source: Second University of Naples
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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 .

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: March 2016
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 14 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Reuterin D3 drops
5 drops/day for 3 months

Other:
• Placebo
5 drops/day for 3 months

Locations

Country	Name	City	State
Italy	Second University of Naples	Naples

Sponsors (1)

Lead Sponsor	Collaborator
Second University of Naples

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of allergic bronchial inflammation	Reduction of FeNO values	Up to 3 months	Yes
Primary	Reduction of allergic bronchial inflammation	Reduction of a series of markers of bronchial inflammation: IL-2; IL-4; IL-10; IFN-?.	Up to 3 months	Yes
Secondary	Improvement of asthma control by C-ACT	Improvement in asthma control assessed by: C-ACT (Scores > 19)	Up to 3 months	Yes
Secondary	Improvement of asthma control by reduction of bronchodilator	Improvement in asthma control assessed by: Reduction use of bronchodilator	Up to 3 months	Yes
Secondary	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	Yes