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Effectiveness of Bifidobacteria in Children Affected by Seasonal Allergic Rhinitis

Seasonal Allergic Rhinitis Clinical Trial

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

Clinical Trial Summary

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

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02807064
Study type Interventional
Source University of Campania "Luigi Vanvitelli"
Contact Michele MD Miraglia del Giudice, Prof
Phone +39.81.5665922
Email michele.miragliadelgiudice@unina2.it
Status Recruiting
Phase Phase 3
Start date December 2016
Completion date July 2019
View Details
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