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Effectiveness of Bifidobacteria in Children Affected by Seasonal Allergic Rhinitis

NCT02807064 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2018-06-26

No results posted yet for this study

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

Conditions

  • Seasonal Allergic Rhinitis

Interventions

DRUG

Bifidobacteria

0.5 ml per os all days for 2 months

DRUG

placebo

0,5 ml per os all days for 2 months

Sponsors & Collaborators

  • University of Campania Luigi Vanvitelli

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-31
Primary Completion
2018-07-31
Completion
2019-07-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02807064 on ClinicalTrials.gov