Effectiveness of Bifidobacteria in Children Affected by Seasonal Allergic Rhinitis
Primary Purpose
Seasonal Allergic Rhinitis
Status
Unknown status
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Bifidobacteria
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Seasonal Allergic Rhinitis
Eligibility 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.
Sites / Locations
- Second UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Bifidobacteria mixture 0.5 ml
placebo
Arm Description
Bifidobacteria 0.5 ml per os all days for 2 months
Placebo 0.5 ml per os all days for 2 months
Outcomes
Primary Outcome Measures
Evaluation of the symptoms by structural questionary
Secondary Outcome Measures
Full Information
NCT ID
NCT02807064
First Posted
June 10, 2016
Last Updated
June 25, 2018
Sponsor
University of Campania "Luigi Vanvitelli"
1. Study Identification
Unique Protocol Identification Number
NCT02807064
Brief Title
Effectiveness of Bifidobacteria in Children Affected by Seasonal Allergic Rhinitis
Official Title
Evaluation of the Effectiveness of Treatment With Bifidobacteria in Children Affected by Seasonal Allergic Rhinitis
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Unknown status
Study Start Date
December 2016 (Actual)
Primary Completion Date
July 2018 (Anticipated)
Study Completion Date
July 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Campania "Luigi Vanvitelli"
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seasonal Allergic Rhinitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Bifidobacteria mixture 0.5 ml
Arm Type
Active Comparator
Arm Description
Bifidobacteria 0.5 ml per os all days for 2 months
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Placebo 0.5 ml per os all days for 2 months
Intervention Type
Drug
Intervention Name(s)
Bifidobacteria
Other Intervention Name(s)
longum infantis M16V
Intervention Description
0.5 ml per os all days for 2 months
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
0,5 ml per os all days for 2 months
Primary Outcome Measure Information:
Title
Evaluation of the symptoms by structural questionary
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michele MD Miraglia del Giudice, Prof
Phone
+39.81.5665922
Email
michele.miragliadelgiudice@unina2.it
Facility Information:
Facility Name
Second University
City
Naples
ZIP/Postal Code
80138
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michele MD Miraglia del Giudice, Prof
Phone
+39.815665922
Email
michele.miragliadelgiudice@unina2.it
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
28270216
Citation
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.
Results Reference
derived
Learn more about this trial
Effectiveness of Bifidobacteria in Children Affected by Seasonal Allergic Rhinitis
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