drugset / Trial / NCT02807064

Effectiveness of Bifidobacteria in Children Affected by Seasonal Allergic Rhinitis

NCT02807064 ↗

Phase 3 Unknown 40 enrolled University of Campania Luigi Vanvitelli
RandomizedParallel-groupDouble-blindTreatment

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

Timeline

Start
2016-12
Primary completion
2018-07
Completion
2019-07

Drugs

EvaluationDrugModalityDoseRoute
Comparator B longum BB536 Other / unclassified 3e+09 unknown Oral
Comparator Bifidobacterium breve M-16V Other / unclassified 1e+09 unknown Oral
Comparator Bifidobacterium infantis M-63 Other / unclassified 1e+09 unknown Oral