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 Details — Status: Recruiting

Administrative data

• NCT number: NCT02807064
• Other study ID #: TRB01
• Status: Recruiting
• Phase: Phase 3
• Start date: December 2016
• Est. completion date: July 2019

Study information

• Verified date: June 2018
• Source: University of Campania "Luigi Vanvitelli"
• Contact: Michele MD Miraglia del Giudice, Prof
• Phone: +39.81.5665922
• Email: michele.miragliadelgiudice[@]unina2.it
• Is FDA regulated: No
• Study type: Interventional

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: July 2019
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Rhinitis
• Rhinitis, Allergic
• Rhinitis, Allergic, Seasonal
• Seasonal Allergic Rhinitis

Intervention

Drug:
• Bifidobacteria
0.5 ml per os all days for 2 months
• placebo
0,5 ml per os all days for 2 months

Locations

Country	Name	City	State
Italy	Second University	Naples

Sponsors (1)

Lead Sponsor	Collaborator
University of Campania "Luigi Vanvitelli"

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of the symptoms by structural questionary		2 months