Dataset Information

Lactobacillus helveticus SBT2171 Alleviates Perennial Allergic Rhinitis in Japanese Adults by Suppressing Eosinophils: A Randomized, Double-Blind, Placebo-Controlled Study.

ABSTRACT: This article examines the effects of fermented milk (FM) containing Lactobacillus helveticus SBT2171 (LH2171) on the subjective symptoms of individuals with mild and moderate perennial allergy. Two hundred subjects were divided into two groups and consumed FM containing LH2171 or placebo FM once per day for 16 weeks. The primary endpoints were defined as per the degree of nasal and ocular symptoms and difficulty in daily life as determined by the Japanese guidelines for allergy rhinitis and the Japanese allergic rhinitis standard quality of life questionnaire, respectively. The secondary endpoints included parameters related to allergic symptoms in the blood and nasal fluids, as well as the mental status. The severity of allergic rhinitis significantly improved in the LH2171 group compared to that in the placebo group. Additionally, the LH2171 group showed a significantly lower degree of "stuffy nose" (as per the diary survey) than the placebo group. Eosinophil counts in the nasal fluids and in the blood were significantly lower in the LH2171 group compared to the placebo group. Thus, the oral administration of FM containing LH2171 cells alleviated perennial allergic rhinitis in individuals with mild and moderate symptoms, possibly via suppression of eosinophils in both the blood and nasal fluids.

SUBMITTER: Yamashita M

PROVIDER: S-EPMC7760906 | biostudies-literature | 2020 Nov

REPOSITORIES: biostudies-literature

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<i>Lactobacillus helveticus</i> SBT2171 Alleviates Perennial Allergic Rhinitis in Japanese Adults by Suppressing Eosinophils: A Randomized, Double-Blind, Placebo-Controlled Study.

Yamashita Maya M Miyoshi Masaya M Iwai Masayuki M Takeda Ryuji R Ono Takahiro T Kabuki Toshihide T

Nutrients 20201125 12

This article examines the effects of fermented milk (FM) containing <i>Lactobacillus helveticus</i> SBT2171 (LH2171) on the subjective symptoms of individuals with mild and moderate perennial allergy. Two hundred subjects were divided into two groups and consumed FM containing LH2171 or placebo FM once per day for 16 weeks. The primary endpoints were defined as per the degree of nasal and ocular symptoms and difficulty in daily life as determined by the Japanese guidelines for allergy rhinitis a ...[more]

PMID: 33255731

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Project description:Background: This study was conducted to evaluate the safety and tolerability, and population pharmacokinetics (PPK) of montelukast as well as efficacy in the treatment of perennial allergic rhinitis (PAR) in paediatric Japanese patients aged between 1 and 15 years. Methods: In this multi-centre, open-label trial, 87 paediatric Japanese patients with PAR received montelukast 4?mg oral granules (OG) for 4 weeks (1-5-year-olds, N?=?15), 4?mg OG for 12 weeks (1-5-year-olds, N?=?36), 5?mg chewable tablets (CT) for 12 weeks (6-9-year-olds, N?=?18), or 5?mg CT for12 weeks (10-15-year-olds, N?=?18). Clinical exams and laboratory assessments were conducted at study visits, and adverse events (AE) were monitored throughout the study up to 14 days after the last visit. Population pharmacokinetic approach was used to estimate AUC0-?, Cmax, Tmax and apparent elimination half-life in each age group. Efficacy was assessed based on global evaluations by the subject's caregiver. Results: There were no serious AEs and one discontinuation due to an AE. The most common AEs in any of the treatment groups were nasopharyngitis, pharyngitis, and acute sinusitis. Montelukast exposure (AUC0-?) was similar in the 1-5-year-old group and the 6-9-year-old group, but 19% lower in the 10-15-year-old group. Among all patients, the total proportion of patients whose global evaluation was "very much better" was 5.7% (week 2), 11.5% (week 4), and 16.9% (week 12) reflecting improvement in symptoms over time. Conclusion: Montelukast was generally well tolerated in Japanese children with PAR. AUC0-?was similar in 1-5 and 6-9-year-olds, while a lower exposure was observed in the 10-15-year-old group likely due to differences in bodyweight. The exposure in Japanese paediatric patients was generally consistent with that in non-Japanese paediatric and adult patients. As assessed by the patients' caregivers, montelukast also demonstrated symptomatic improvement based on global evaluations of PAR.

Project description:Background:Allergic respiratory diseases such as allergic rhinitis (AR) and allergic asthma (AA) are common conditions that can influence sleep and daytime functioning. However, the significance of this impact is unclear-particularly in perennial allergy sufferers. This study investigates the impact of perennial allergy on sleep, daily activities and productivity. Methods:Adults with self-reported or physician-diagnosed perennial AR aged ??18 years were recruited in Denmark, France, Germany and Sweden. Allergy sufferers were identified using online panels closely matching national population characteristics for each country. Impact on sleep, work, productivity and activity (by the Work, Productivity and Activity Index) were analysed. Descriptive analyses were conducted. Results:In total, 511 subjects with perennial AR (47.4% also with seasonal allergy) completed the survey. Most subjects (77.5%) had a physician-diagnosis of AR; 46.4% were diagnosed with both AA and AR. Most subjects (65.2%) reported sensitisation to house dust mites. Of all subjects, 66.0% reported sleep problems. Subjects with sleep problems woke, on average, 3.8 times per night, with 92.0% taking 15+ min to fall asleep (22.2% took 60+ min). Upon waking at night, 40.8% struggled to get back to sleep, and 69.2% had difficulties waking in the morning due to tiredness. Disturbances in daily functioning due to sleep issues were reported in 85.5-95.0% of subjects with sleep problems across all aspects investigated. Overall work and activity impairment were 53.3% and 47.1%, respectively. Sleep issues were more frequent (78.1% vs 54.7%) in those diagnosed with both AR and AA compared to AR alone, and more burdensome, with a greater impact on daily functioning (47.0% vs 33.3%) and impairment in work and activity (62.0% and 54.9% vs 39.3% and 35.2%, respectively). Of all subjects, 20.5% were receiving AIT at the time of the survey; of these, 36.4% reported moderate or great improvement in sleep due to allergy treatment. Conclusions:In perennial AR sufferers, sleep problems are common and impact on daily functioning, with results indicating a greater burden in those with both AR and AA compared to AR alone.

Dataset Information

Lactobacillus helveticus SBT2171 Alleviates Perennial Allergic Rhinitis in Japanese Adults by Suppressing Eosinophils: A Randomized, Double-Blind, Placebo-Controlled Study.

Publications

<i>Lactobacillus helveticus</i> SBT2171 Alleviates Perennial Allergic Rhinitis in Japanese Adults by Suppressing Eosinophils: A Randomized, Double-Blind, Placebo-Controlled Study.

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