Beneficial Effects of Lactobacillus Reuteri DSM 17938 Supplementation on Asthmatic Children

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Prof. Michele Miraglia del Giudice, Federico II University
ClinicalTrials.gov Identifier:
NCT01241084
First received: November 15, 2010
Last updated: September 29, 2011
Last verified: September 2011
  Purpose

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.


Condition Intervention
Airways Allergic Inflammation of Asthmatic Children
Dietary Supplement: Antileukotrienes + Lactobacillus reuteri
Dietary Supplement: Antileukotrienes + Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Beneficial Effects of Lactobacillus Reuteri DSM 17938 Supplementation on the Airways Allergic Inflammation of Asthmatic Children

Resource links provided by NLM:


Further study details as provided by Federico II University:

Primary Outcome Measures:
  • Beneficial effects of Lactobacillus reuteri supplementation on asthmatic children [ Time Frame: two months ] [ Designated as safety issue: Yes ]

    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.



Enrollment: 50
Study Start Date: June 2009
Study Completion Date: June 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   6 Years to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Participation to other clinical trials
  • Informed consent not signed
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01241084

Locations
Italy
AOU "Federico II" di Napoli
Napoli, Italy
Sponsors and Collaborators
Federico II University
Investigators
Principal Investigator: Michele Miraglia del Giudice, MD AOU "Federico II" di Napoli
  More Information

No publications provided

Responsible Party: Prof. Michele Miraglia del Giudice, MD, Federico II University
ClinicalTrials.gov Identifier: NCT01241084     History of Changes
Other Study ID Numbers: Lr_Asthma
Study First Received: November 15, 2010
Last Updated: September 29, 2011
Health Authority: Italy: Ethics Committee

Keywords provided by Federico II University:
asthmatic children

Additional relevant MeSH terms:
Asthma
Inflammation
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Pathologic Processes
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 20, 2014