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Beneficial Effects of Lactobacillus Reuteri DSM 17938 Supplementation on Asthmatic Children

NCT01241084 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2011-10-03

No results posted yet for this study

Summary

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.

Conditions

  • Airways Allergic Inflammation of Asthmatic Children

Interventions

DIETARY_SUPPLEMENT

Antileukotrienes + Lactobacillus reuteri

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

DIETARY_SUPPLEMENT

Antileukotrienes + Placebo

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

Sponsors & Collaborators

  • Federico II University

    lead OTHER

Principal Investigators

  • Michele Miraglia del Giudice, MD · AOU "Federico II" di Napoli

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
14 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2010-12-31
Completion
2011-06-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01241084 on ClinicalTrials.gov