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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2016-03-31

Brief Summary

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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 .

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Detailed Description

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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

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Reuterin D3 drops

Lactobacillus reuteri DSM 17938 (108 CFU) + Vitamin D3 (400 IU) 5 drops/day for 3 months (Reuterin D3 drops)

Group Type ACTIVE_COMPARATOR

Reuterin D3 drops

Intervention Type DRUG

5 drops/day for 3 months

Placebo

The patients will receive 5 drops/day of placebo for 3 months

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

5 drops/day for 3 months

Interventions

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Reuterin D3 drops

5 drops/day for 3 months

Intervention Type DRUG

Placebo

5 drops/day for 3 months

Intervention Type OTHER

Other Intervention Names

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Lactobacillus reuteri DSM 17938 + Vit. D3

Eligibility Criteria

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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

Minimum Eligible Age

6 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No