Effectiveness of Bifidobacteria in Children Affected by Seasonal Allergic Rhinitis

• Status: Unknown status
• Trial end date: 2019-07-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Second University of Naples; University of Campania "Luigi Vanvitelli"

Criteria

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.