NCT02807064

Effectiveness of Bifidobacteria in Children Affected by Seasonal Allergic Rhinitis

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: University of Campania Luigi Vanvitelli · Academic / Other
• Sex: All
• Age: 4 Years – 17 Years
• Healthy volunteers: Not accepted

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

Detailed 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.

Conditions

• Seasonal Allergic Rhinitis

Interventions

Type	Name	Description
DRUG	Bifidobacteria	0.5 ml per os all days for 2 months
DRUG	placebo	0,5 ml per os all days for 2 months

Timeline

• Start date: 2016-12-01
• Primary completion: 2018-07-01
• Completion: 2019-07-01
• First posted: 2016-06-21
• Last updated: 2018-06-26

Locations

1 site across 1 country: Italy