Effectiveness of Bifidobacteria in Children Affected by Seasonal Allergic Rhinitis

NCT02807064 | Unknown Phase 3

• 1 other identifier: TRB01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Seasonal Allergic Rhinitis

Outcome Measures

Primary Outcomes (1)

• Evaluation of the symptoms by structural questionary

  2 months

Study Arms (2)

Bifidobacteria mixture 0.5 ml

ACTIVE COMPARATOR

Bifidobacteria 0.5 ml per os all days for 2 months

Drug: Bifidobacteria

placebo

PLACEBO COMPARATOR

Placebo 0.5 ml per os all days for 2 months

Drug: placebo

Interventions

Bifidobacteria DRUG

0.5 ml per os all days for 2 months

Also known as: longum infantis M16V

Bifidobacteria mixture 0.5 ml

placebo DRUG

0,5 ml per os all days for 2 months

placebo

Eligibility Criteria

• Age: 4 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Campania Luigi Vanvitelli: lead

Study Sites (1)

Second University

Naples, 80138, Italy

RECRUITING

Related Publications (1)

• 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.

  PMID: 28270216 DERIVED

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal

Condition Hierarchy (Ancestors)

Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Central Study Contacts

Michele MD Miraglia del Giudice, Prof

CONTACT

+39.81.5665922; michele.miragliadelgiudice@unina2.it

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Associato

Study Record Dates

• First Submitted: June 10, 2016
• First Posted: June 21, 2016
• Study Start: December 1, 2016
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2019
• Last Updated: June 26, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)