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Treatment with a Probiotic Mixture Containing Bifidobacterium animalis Subsp. Lactis BB12 and Enterococcus faecium L3 for the Prevention of Allergic Rhinitis Symptoms in Children: A Randomized Controlled Trial.

  • 2021-04-16
  • Nutrients 13(4)
    • Caterina Anania
    • Vincenza Patrizia Di Marino
    • Francesca Olivero
    • Daniela De Canditiis
    • Giulia Brindisi
    • Federico Iannilli
    • Giovanna De Castro
    • Anna Maria Zicari
    • Marzia Duse

Study Design

Type
Randomized Controlled Trial (RCT)
Sample size
n = 250
Population
250 children aged from 6 to 17 years, affected by AR
Methods
Randomly assigned to the intervention group (150) or to the placebo group (100); intervention group received daily oral administration of a probiotic mixture containing Bifidobacterium animalis subsp. Lactis BB12 DSM 15954 and Enterococcus faecium L3 LMG P-27496 strain for 3 months preceding the onset of symptoms, in addition to conventional therapy
Blinding
Open-label
Duration
3 months
Funding
Unclear
  • Large Human Trial
  • Rigorous Journal

Background

Probiotics may prevent the allergic response development due to their anti-inflammatory and immunomodulatory effects. The aim of this study is to determine if the prophylactic treatment with a mixture of Bifidobacterium animalis subsp. Lactis BB12 and Enterococcus faecium L3 would reduce symptoms and need for drug use in children with allergic rhinitis (AR).

Methods

The study included 250 children aged from 6 to 17 years, affected by AR. Patients were randomly assigned to the intervention group (150) or to the placebo group (100). Patients in the intervention group, in addition to conventional therapy (local corticosteroids and/or oral antihistamines), were treated in the 3 months preceding the onset of symptoms related to the presence of the allergen to which the children were most sensitized, with a daily oral administration of a probiotic mixture containing the Bifidobacterium animalis subsp. Lactis BB12 DSM 15954 and the Enterococcus faecium L3 LMG P-27496 strain. We used Nasal Symptoms Score (NSS) to evaluate AR severity before and after the treatment with probiotics or placebo.

Results

the patients in the intervention group had a significant reduction in their NSS after probiotic treatment (p-value = 2.2 × 10-10. Moreover, for the same group of patients, we obtained a significant reduction in the intake of pharmacological therapy. In particular, we obtained a reduction in the use of oral antihistamines (p-value = 2.2 × 10-16), local corticosteroids (p-value = 2.2 × 10-13), and of both drugs (p-value 1.5 × 10-15).

Conclusions

When administered as a prophylactic treatment, a mixture of BB12 and L3 statistically decreased signs and symptoms of AR and reduced significantly the need of conventional therapy.

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