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Beneficial Effects of Lactobacillus Reuteri DSM 17938 Supplementation on Asthmatic Children

NCT ID: NCT01241084

Last Updated: 2011-10-03

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

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2011-06-30

Brief Summary

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Objective The aim of the trial is to evaluate the beneficial effects of the oral administration of the probiotic L. Reuteri (Reuterin®) on the airways allergic inflammation in children with mild to moderate persistent asthma.

Study design This is a randomized, double-blind, placebo controller trial. 50 children will be enrolled (age range 6-14 years), affected by mild to moderate persistent asthma based on the GINA Guidelines and allergic to acarus (Dermatophagoides farinae and D. pteronyssinus ++/+++). At the enrollment period all children have to show asthmatic symptoms and to be under antileukotrienes treatment (Montelukast 5mg/die) based on the GINA Guidelines. Any inhaling corticosteroids therapies have to be stopped 8 weeks before the trial beginning.

Patients will be randomly divided into 2 treatment groups:

Group A: 25 patients will take antileukotrienes + L. reuteri drops (108 CFU = 5 drops daily).

Group B: 25 patients will take antileukotrienes + placebo. At the enrollment period (T0), after the 1st and the 2nd month of supplementation (T1 and T2), and also 1 month after the supplementation end (T3), all patients will be clinically evaluated through spirometry, FeNO determination and exhale condensate analysis.

During the entire trial period the number of asthmatic exacerbations and the use of beta-2 antagonists will be monitored by a diary properly examined at T1, T2 and T3.

All children will be enrolled at the Asthma and Infant Respiratory Physiopathology unit "Michele Miraglia del Giudice" of the "F. Fede" Pediatric Department.

The analysis of the inflammatory markers on the exhaled condensate will be performer at T1, T2 and T3 in the Pharmacology unit of the Experimental Medicine Department.

During the trial it will be possible to administer only salbutamole MDI if it needed. If patients will be administered with any systemic corticosteroids they will exit from the trial.

At the enrolment period all patients will receive the completed information on the trial and the informed consent will be properly signed.

Detailed Description

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Conditions

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Airways Allergic Inflammation of Asthmatic Children

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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Placebo

Antileukotrienes+Placebo

Group Type PLACEBO_COMPARATOR

Antileukotrienes + Placebo

Intervention Type DIETARY_SUPPLEMENT

Montelukast (5mg/die) + 5 drops of placebo daily for 2 months

Lactobacillus reuteri

Antileukotrienes+Lactobacillus reuteri

Group Type ACTIVE_COMPARATOR

Antileukotrienes + Lactobacillus reuteri

Intervention Type DIETARY_SUPPLEMENT

Montelukast (5mg/die) + 1000000000 CFU per day (5 drops) for 2 months

Interventions

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Antileukotrienes + Lactobacillus reuteri

Montelukast (5mg/die) + 1000000000 CFU per day (5 drops) for 2 months

Intervention Type DIETARY_SUPPLEMENT

Antileukotrienes + Placebo

Montelukast (5mg/die) + 5 drops of placebo daily for 2 months

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Children with age range 6-14 years
* Informed consent signed

Exclusion Criteria

* Participation to other clinical trials
* Informed consent not signed
Minimum Eligible Age

6 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Federico II University

OTHER

Sponsor Role lead

Responsible Party

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Prof. Michele Miraglia del Giudice

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michele Miraglia del Giudice, MD

Role: PRINCIPAL_INVESTIGATOR

AOU "Federico II" di Napoli

Locations

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AOU "Federico II" di Napoli

Napoli, , Italy

Site Status

Countries

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Italy

Other Identifiers

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Lr_Asthma

Identifier Type: -

Identifier Source: org_study_id