Effectiveness of Bifidobacteria in Children Affected by Seasonal Allergic Rhinitis

NCT ID: NCT02807064

Last Updated: 2018-06-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-31
• Study Completion Date: 2019-07-31

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.

Conditions

Seasonal Allergic Rhinitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Bifidobacteria mixture 0.5 ml

Bifidobacteria 0.5 ml per os all days for 2 months

Group Type: ACTIVE_COMPARATOR

Bifidobacteria

Intervention Type: DRUG

0.5 ml per os all days for 2 months

placebo

Placebo 0.5 ml per os all days for 2 months

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

0,5 ml per os all days for 2 months

Interventions

Bifidobacteria

0.5 ml per os all days for 2 months

Intervention Type: DRUG

placebo

0,5 ml per os all days for 2 months

Intervention Type: DRUG

Other Intervention Names

longum infantis M16V

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.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Campania Luigi Vanvitelli

OTHER

Sponsor Role: lead

Responsible Party

Prof. Michele Miraglia del Giudice

Prof. Associato

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Second University

Naples, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Michele MD Miraglia del Giudice, Prof

Role: CONTACT

michele.miragliadelgiudice@unina2.it

+39.81.5665922

Facility Contacts

Michele MD Miraglia del Giudice, Prof

Role: primary

michele.miragliadelgiudice@unina2.it

+39.815665922

References

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.

Reference Type: DERIVED

PMID: 28270216 (View on PubMed)

Other Identifiers

TRB01

Identifier Type: -

Identifier Source: org_study_id