CLINICAL TRIAL article

Front. Nutr.

Sec. Nutritional Immunology

Volume 12 - 2025 | doi: 10.3389/fnut.2025.1568329

This article is part of the Research TopicCommunity Series in Targeted Innovative Immunomodulation of Allergy and Inflammation by Natural Molecules and Probiotics: Volume IIView all 7 articles

Effect of Heat-Killed Lacticaseibacillus paracasei KW3110 on Mild to Moderate Seasonal Allergic Rhinitis Symptoms in Japanese adults: A Randomized, Double-Blind, Placebo-Controlled Parallel-Group Study

Provisionally accepted
Yoshihiko  SugiharaYoshihiko Sugihara1Jiawen  ZhengJiawen Zheng1Yuko  FukushimaYuko Fukushima1Hajime  NozawaHajime Nozawa1Yusuke  UshidaYusuke Ushida1*Ryohei  TsujiRyohei Tsuji1Yoshitaka  OkamotoYoshitaka Okamoto2Daisuke  FujiwaraDaisuke Fujiwara1
  • 1nstitute of Health Sciences, Health Science Business Division, Kirin Holdings Company Ltd., Fujisawa, Japan
  • 2Chiba Rosai Hospital, Chiba, Japan

The final, formatted version of the article will be published soon.

Background: In recent years, the prevalence of seasonal allergic rhinitis has increased rapidly in Japan, becoming a social problem. Therefore, we evaluated the effect of tablets containing Lacticaseibacillus paracasei KW3110 (L. paracasei KW3110) on allergic symptoms in the nose and eyes. Methods: In a randomized, double-blind, placebo-controlled, parallel-group study, 120 healthy adults with mild to moderate allergic rhinitis ingested either a placebo tablet or a test tablet containing L. paracasei KW3110 for 12 weeks (from January to April). Subjects who did not regularly use medication and experienced nasal and eye discomfort in early spring were selected. Allergic symptoms in the nose and eyes were assessed using subjective symptom surveys and diagnosis by an otorhinolaryngologist. Results: Compared with the placebo group, the L. paracasei KW3110 group showed a significant improvement in the score of "nasal symptoms" (p < 0.05) and "outdoor activities" (p < 0.05) in the Japanese Rhino-conjunctivitis Quality of Life Questionnaire (JRQLQ No.1) at 4 weeks when pollen dispersal begins, and "runny nose" (p < 0.05) in a diary questionnaire on nasal and eye symptoms at 8 weeks. Diagnosis by an otorhinolaryngologist showed a significant decrease in the score of "paroxysmal sneezing or rhinorrhea" (p < 0.05) and "classification of severity of allergic rhinitis symptoms" (p < 0.05) at 4 weeks, and the number of subjects scoring "worse" (p < 0.05) in the efficacy assessment. Conclusion: These findings suggest that intake of L. paracasei KW3110 is effective in alleviating nasal symptoms in subjects with mild to moderate allergic rhinitis, which can be useful for preventing allergic rhinitis without medication. Clinical Trial Registration: https://www.umin.ac.jp/, identifier UMIN000053239.

Keywords: Lacticaseibacillus paracasei KW3110, Lactic acid bacteria, allergic rhinitis, Probiotics, Cedar pollen

Received: 29 Jan 2025; Accepted: 23 May 2025.

Copyright: © 2025 Sugihara, Zheng, Fukushima, Nozawa, Ushida, Tsuji, Okamoto and Fujiwara. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

* Correspondence: Yusuke Ushida, nstitute of Health Sciences, Health Science Business Division, Kirin Holdings Company Ltd., Fujisawa, Japan

Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.