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

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

Study Overview

• Status: Unknown
• Conditions: Seasonal Allergic Rhinitis
• Intervention / Treatment: Drug: Bifidobacteria; Drug: placebo

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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 3

Contacts and Locations

Study Locations

• Italy
  • Naples, Italy, 80138
    • Recruiting
    • Second University
    • Contact: Michele MD Miraglia del Giudice, Prof; Phone Number: +39.815665922; Email: michele.miragliadelgiudice@unina2.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Bifidobacteria mixture 0.5 ml; Bifidobacteria 0.5 ml per os all days for 2 months	Drug: Bifidobacteria; 0.5 ml per os all days for 2 months; Other Names: longum infantis M16V
Placebo Comparator: placebo; Placebo 0.5 ml per os all days for 2 months	Drug: placebo; 0,5 ml per os all days for 2 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Evaluation of the symptoms by structural questionary	2 months

Collaborators and Investigators

• Sponsor: University of Campania "Luigi Vanvitelli"

Publications and helpful links

General Publications

• Miraglia Del Giudice M, Indolfi C, Capasso M, Maiello N, Decimo F, Ciprandi G. Bifidobacterium mixture (B longum BB536, B infantis M-63, B breve M-16V) treatment in children with seasonal allergic rhinitis and intermittent asthma. Ital J Pediatr. 2017 Mar 7;43(1):25. doi: 10.1186/s13052-017-0340-5.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2016
• Primary Completion (Anticipated): July 1, 2018
• Study Completion (Anticipated): July 1, 2019

Study Registration Dates

• First Submitted: June 10, 2016
• First Submitted That Met QC Criteria: June 20, 2016
• First Posted (Estimate): June 21, 2016

Study Record Updates

• Last Update Posted (Actual): June 26, 2018
• Last Update Submitted That Met QC Criteria: June 25, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
• Other Study ID Numbers: TRB01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO