Effectiveness of Bifidobacteria in Children Affected by Seasonal Allergic Rhinitis

Study Overview
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Brief Summary
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This study is aimed at assessing the efficacy of supplementation with a mixture of three bifidobacteria , on the allergic rhinitis..The rhinitis symptoms were assessed by validated score ( TSS ) , for children aged between 4 and 17 years with allergic rhinitis parietaria , mild , moderate or severe , than children not supplemented . Secondary Objectives The effectiveness of treatment by VAS : Evaluation of the rescue medication consumption Evaluation of quality of life ( using structured questionnaire ) Evaluation of the frequency and school performance ( using structured questionnaire ) Assessment of sleep quality and attention (through structured questionnaire ) Satisfaction rating and satisfaction of parents Evaluation of asthma exacerbations in children susceptible

Detailed Description
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This is a randomized , double-blind , placebo - controlled , phase 3 , 2 arms , in which patients were selected to receive placebo or a mixture powder composed of three bifidobacteria : Bifidobacterium Longum BB536 ( 3 billion units ) + Bifidobacterium infantis M - 63 ( 1 billion units ) Bifidobacterium breve M + -16 V ( 1 billion units ) . The subjects included in our study are represented by children aged between 4 and 17 years , with seasonal allergic rhinitis moderate and presenting positive skin prick test against parietaria.The participation of each subject in the study was based on evaluation of its clinical history. The recruited patients were divided into two groups according to the drug used.The group A received placebo , while the group B mixture bifidobacteria. The treatment was performed for a period of two months. At the beginning and at the end of therapy several surveys have been carried out , so as to be able to compare results and to draw some preliminary conclusions about the effectiveness of treatment.

Official Title
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Evaluation of the Effectiveness of Treatment With Bifidobacteria in Children Affected by Seasonal Allergic Rhinitis

Conditions
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Seasonal Allergic Rhinitis

Intervention / Treatment
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* Drug: Bifidobacteria
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children of both sexes , aged from 4 to 17 years History seasonal allergic rhinitis mild , moderate or severe , according to the guidelines defined AIR 2013 , documented by recurrent episodes in the previous year and confirmed by skin prick test positive Written informed consent of one parent or a legal representative Exclusion Criteria: Lack of written informed consent by at least one parent or a legal representative Concurrent disorders such as infection of the upper or lower respiratory tract , nasal surgery in the past year , respiratory tract abnormalities , immune diseases Use of antihistamines , nasal or systemic corticosteroids , leukotriene modifiers , or cromolyn sodium , on an ongoing basis used in the last six weeks.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bifidobacteria mixture 0.5 ml<br>Bifidobacteria 0.5 ml per os all days for 2 months | Drug: Bifidobacteria<br>* 0.5 ml per os all days for 2 months<br>* Other names: longum infantis M16V;|
| Placebo Comparator: placebo<br>Placebo 0.5 ml per os all days for 2 months | Drug: placebo<br>* 0,5 ml per os all days for 2 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the symptoms by structural questionary |  | 2 months |