A Phase 3 interventional study of Bifidobacteria and placebo in Seasonal Allergic Rhinitis, sponsored by University of Campania Luigi Vanvitelli. Status unknown at 1 site in Italy. Open to participants aged 4 Years to 17 Years. Per ClinicalTrials.gov, last updated 2018-06-26.
Sponsored by University of Campania Luigi Vanvitelli · Phase 3, Interventional, and Treatment
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
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.
1,105 studies on the registry are indexed under Rhinitis; 65 are open to participants now.
This study's planned enrollment of 40 is below the median of 89 across 906 interventional studies indexed under Rhinitis.
Browse Rhinitis studies →University of Campania Luigi Vanvitelli is the lead sponsor of 170 studies on the registry; 26 are open to participants now.
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Exclusion Criteria:
Bifidobacteria 0.5 ml per os all days for 2 months
Drug: Bifidobacteria
Placebo 0.5 ml per os all days for 2 months
Drug: placebo
0.5 ml per os all days for 2 months
Also known as: longum infantis M16V
0,5 ml per os all days for 2 months
Evaluation of the symptoms by structural questionary
Time frame: 2 months
Plan to share: No
This study is status unknown, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.
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University of Campania Luigi Vanvitelli