Beneficial Effects of Lactobacillus Reuteri DSM 17938 Supplementation on Asthmatic Children
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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 |
- 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 |
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 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 May 19, 2013