J Korean Med Sci.  2024 Oct;39(40):e266. 10.3346/jkms.2024.39.e266.

Efficacy of Bifidobacterium longum and Lactobacillus plantarum (NVP-1703) in Children With Allergic Rhinitis: A Randomized Controlled Trial

Affiliations
  • 1Department of Pediatrics, Ajou University School of Medicine, Suwon, Korea
  • 2PB Department, NVP Healthcare Co., Ltd., Suwon, Korea
  • 3Department of Pediatrics, Seoul National University College of Medicine, Seoul, Korea

Abstract

Background
There is increasing evidence that probiotics are effective in treating allergic rhinitis (AR), while some controversies remain. This study was performed to evaluate the therapeutic effect and safety of a mixture of Bifidobacterium longum and Lactobacillus plantarum (NVP-1703) in children with AR.
Methods
In a randomized, double-blind, placebo-controlled study, children aged 6 to 19 years with perennial AR were treated with NVP-1703 at a dose of 1 × 1010 CFU/day or placebo once a day for 4 weeks. Total nasal symptom score (TNSS), nasal symptom duration score (NSDS), quality of life (QoL), allergic inflammatory markers, and safety parameters were evaluated.
Results
After 4 weeks of treatment, the TNSS in the NVP-1703 group significantly decreased compared to that in the placebo group (P = 0.011), both in the morning and the evening (P = 0.031 and P = 0.004, respectively). The NSDS also significantly decreased in the NVP-1703 group compared to that in the placebo group (P = 0.018). QoL scores, particularly those related to mouth breathing and itchy nose, showed a significant improvement in the NVP-1703 group compared to the placebo group. The ratios of interleukin (IL)-4/IL-22 and IL-5/IL-22 were significantly reduced in the NVP-1703 group after the treatment compared to the baseline values. No notable adverse events were reported in the NVP-1703 group.
Conclusion
Oral administration of a mixture of B. longum and L. plantarum (NVP-1703) improved both AR symptoms and QoL in children with perennial AR, accompanied by decreases in the ratios of T helper 2 cytokines to IL-22.

Keyword

Allergy; Microbiota; Nasal Symptoms; Probiotics; Quality of Life

Figure

  • Fig. 1 NVP-1703 clinical trial flowchart.

  • Fig. 2 Effect of NVP-1703 on AR symptoms and duration. Effect of NVP-1703 on (A) daily TNSS, (B) weekly AR symptom scores, and (C) AR symptom duration scores. Scores are shown as mean change from the baseline for the TNSS and subscale score of TNSS or NSDS during the study period. Data are expressed as mean ± standard error of the mean.TNSS = total nasal symptom score, AR = allergic rhinitis, NSDS = nasal symptom duration score.*P< 0.05, **P< 0.01, ***P< 0.001.

  • Fig. 3 Effects of NVP-1703 on QoL-KCAR. Data are expressed as mean ± standard error of the mean.QoL-KCAR = Quality of Life Questionnaire in Korean Children with Allergic Rhinitis.*P < 0.05.

  • Fig. 4 Effects of NVP-1703 on blood levels of IL-22, cytokines/IL-22, IL-10, and cytokines/IL-10. Effect of NVP-1703 on blood levels of IL-22, IL-10, and associated cytokine ratios. (A) Effect of NVP-1703 on blood levels of IL-22 and associated cytokine ratios, (B) Effect of NVP-1703 on blood levels of IL-10 and associated cytokine ratios.IL = interleukin, IFN = interferon.*P < 0.05.


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