Beneficial Effects of Lactobacillus Reuteri DSM 17938 Supplementation on Asthmatic Children

Beneficial Effects of Lactobacillus Reuteri DSM 17938 Supplementation on the Airways Allergic Inflammation of Asthmatic Children

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.

Study Overview

• Status: Completed
• Conditions: Airways Allergic Inflammation of Asthmatic Children
• Intervention / Treatment: Dietary supplement: Antileukotrienes + Placebo; Dietary supplement: Antileukotrienes + Lactobacillus reuteri

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Napoli, Italy
    • AOU "Federico II" di Napoli

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 14 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Participation to other clinical trials
• Informed consent not signed

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo; Antileukotrienes+Placebo	Dietary supplement: Antileukotrienes + Placebo; Montelukast (5mg/die) + 5 drops of placebo daily for 2 months
ACTIVE_COMPARATOR: Lactobacillus reuteri; Antileukotrienes+Lactobacillus reuteri	Dietary supplement: Antileukotrienes + Lactobacillus reuteri; Montelukast (5mg/die) + 1000000000 CFU per day (5 drops) for 2 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Beneficial effects of Lactobacillus reuteri supplementation on asthmatic children	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. . At the enrolment 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.	two months

Collaborators and Investigators

• Sponsor: Federico II University
• Investigators: Principal Investigator: Michele Miraglia del Giudice, MD, AOU "Federico II" di Napoli

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (ACTUAL): December 1, 2010
• Study Completion (ACTUAL): June 1, 2011

Study Registration Dates

• First Submitted: November 15, 2010
• First Submitted That Met QC Criteria: November 15, 2010
• First Posted (ESTIMATE): November 16, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): October 3, 2011
• Last Update Submitted That Met QC Criteria: September 29, 2011
• Last Verified: September 1, 2011

More Information

Terms related to this study

• Keywords: asthmatic children
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Inflammation; Asthma; Physiological Effects of Drugs; Hormones, Hormone Substitutes, and Hormone Antagonists; Anti-Asthmatic Agents; Respiratory System Agents; Hormone Antagonists; Leukotriene Antagonists
• Other Study ID Numbers: Lr_Asthma