A D Grant, M C B Erfe, C J Delebecque, D Keller, N P Zimmerman, P L Oliver, B Youssef, J Moos, V Luna, N Craft
{"title":"植物乳杆菌Lp815减少轻度至中度焦虑患者的焦虑:一项直接面向消费者的、随机、双盲、安慰剂对照研究。","authors":"A D Grant, M C B Erfe, C J Delebecque, D Keller, N P Zimmerman, P L Oliver, B Youssef, J Moos, V Luna, N Craft","doi":"10.1163/18762891-bja00073","DOIUrl":null,"url":null,"abstract":"<p><p>The major inhibitory neurotransmitter gamma-aminobutyric acid or GABA plays a pivotal role in mood and sleep. GABA exerts sedative and anxiolytic effects both within the central nervous system and through the gut-brain axis, which has generated interest in the potential for gut GABA to modulate mood and sleep. Several bacterial strains can produce GABA, yet their real-world impacts are poorly understood. We investigated the impact of 2 doses of the strain Lactiplantibacillus plantarum Lp815 on anxiety, sleep, mood, quality of life, cognition, heart rate variability and adverse events in adults with mild to moderate anxiety over a 6-week period. The trial was structured as a double-blinded, randomised, placebo-controlled trial with optional open label extension. Participants were blindly assigned to receive either a placebo, 1 billion colony-forming units (CFU), or 5 billion CFU of the oral capsule per day. Participants completed biweekly anxiety, insomnia and cognition measures, daily mood, sleep, and quality of life surveys, and collected wearable heart rate variability. 83 individuals were evaluated, aged 39 ± 13 years, 63% female and 64% Caucasian. Participants receiving 5 billion CFU exhibited significantly lower anxiety (GAD-7) scores at weeks 4 and 6 compared to placebo (Kruskal-Wallis P < 0.05). This result was clinically meaningful, with 68% of participants in the 5 billion CFU cohort exhibiting improvement by more than one category in their GAD-7 scores at week 6, compared to 37% in the 1 billion CFU group and 26% in the placebo group (e.g. from moderate to no anxiety) (Fisher's exact test P = 0.002 for 5 billion CFU vs Placebo). No serious adverse events occurred. A daily capsule containing 5 billion CFU Lp815 significantly reduced anxiety in a diverse cohort of adults at 4 and 6 weeks following daily consumption. GABA-producing probiotics may offer a safe option for anxiety reduction in people with mild to moderate anxiety. Trial Registration. 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引用次数: 0
摘要
主要的抑制性神经递质γ -氨基丁酸或GABA在情绪和睡眠中起着关键作用。GABA在中枢神经系统和肠-脑轴中都有镇静和抗焦虑作用,这引起了人们对肠道GABA调节情绪和睡眠的潜力的兴趣。几种细菌菌株可以产生GABA,但它们对现实世界的影响却知之甚少。我们研究了2剂植物乳杆菌Lp815菌株在6周内对轻度至中度焦虑成人的焦虑、睡眠、情绪、生活质量、认知、心率变异性和不良事件的影响。该试验结构为双盲、随机、安慰剂对照试验,可选择开放标签扩展。参与者被盲目分配接受安慰剂,每天10亿菌落形成单位(CFU)或50亿CFU的口服胶囊。参与者每两周完成一次焦虑、失眠和认知测量,每日情绪、睡眠和生活质量调查,并收集可穿戴心率变异性。83例,年龄39±13岁,63%为女性,64%为白人。与安慰剂相比,接受50亿CFU治疗的参与者在第4周和第6周的焦虑(GAD-7)评分显著降低(Kruskal-Wallis P < 0.05)。这一结果具有临床意义,在50亿CFU队列中,68%的参与者在第6周的GAD-7评分中表现出不止一个类别的改善,而10亿CFU组为37%,安慰剂组为26%(例如,从中度到无焦虑)(50亿CFU vs安慰剂的Fisher精确检验P = 0.002)。未发生严重不良事件。每日服用含有50亿CFU Lp815的胶囊,可在每日服用后4周和6周显著降低不同成年人的焦虑。产生gaba的益生菌可能为轻度至中度焦虑的人提供一种安全的减少焦虑的选择。试验注册。该试验已获得IRB批准并在ClinicalTrials.gov注册(NCT06466603)。
Lactiplantibacillus plantarum Lp815 decreases anxiety in people with mild to moderate anxiety: a direct-to-consumer, randomised, double-blind, placebo-controlled study.
The major inhibitory neurotransmitter gamma-aminobutyric acid or GABA plays a pivotal role in mood and sleep. GABA exerts sedative and anxiolytic effects both within the central nervous system and through the gut-brain axis, which has generated interest in the potential for gut GABA to modulate mood and sleep. Several bacterial strains can produce GABA, yet their real-world impacts are poorly understood. We investigated the impact of 2 doses of the strain Lactiplantibacillus plantarum Lp815 on anxiety, sleep, mood, quality of life, cognition, heart rate variability and adverse events in adults with mild to moderate anxiety over a 6-week period. The trial was structured as a double-blinded, randomised, placebo-controlled trial with optional open label extension. Participants were blindly assigned to receive either a placebo, 1 billion colony-forming units (CFU), or 5 billion CFU of the oral capsule per day. Participants completed biweekly anxiety, insomnia and cognition measures, daily mood, sleep, and quality of life surveys, and collected wearable heart rate variability. 83 individuals were evaluated, aged 39 ± 13 years, 63% female and 64% Caucasian. Participants receiving 5 billion CFU exhibited significantly lower anxiety (GAD-7) scores at weeks 4 and 6 compared to placebo (Kruskal-Wallis P < 0.05). This result was clinically meaningful, with 68% of participants in the 5 billion CFU cohort exhibiting improvement by more than one category in their GAD-7 scores at week 6, compared to 37% in the 1 billion CFU group and 26% in the placebo group (e.g. from moderate to no anxiety) (Fisher's exact test P = 0.002 for 5 billion CFU vs Placebo). No serious adverse events occurred. A daily capsule containing 5 billion CFU Lp815 significantly reduced anxiety in a diverse cohort of adults at 4 and 6 weeks following daily consumption. GABA-producing probiotics may offer a safe option for anxiety reduction in people with mild to moderate anxiety. Trial Registration. The trial was IRB approved and registered with ClinicalTrials.gov (NCT06466603).
期刊介绍:
Beneficial Microbes is a peer-reviewed scientific journal with a specific area of focus: the promotion of the science of microbes beneficial to the health and wellbeing of man and animal. The journal contains original research papers and critical reviews in all areas dealing with beneficial microbes in both the small and large intestine, together with opinions, a calendar of forthcoming beneficial microbes-related events and book reviews. The journal takes a multidisciplinary approach and focuses on a broad spectrum of issues, including safety aspects of pro- & prebiotics, regulatory aspects, mechanisms of action, health benefits for the host, optimal production processes, screening methods, (meta)genomics, proteomics and metabolomics, host and bacterial physiology, application, and role in health and disease in man and animal. Beneficial Microbes is intended to serve the needs of researchers and professionals from the scientific community and industry, as well as those of policy makers and regulators.
The journal will have five major sections:
* Food, nutrition and health
* Animal nutrition
* Processing and application
* Regulatory & safety aspects
* Medical & health applications
In these sections, topics dealt with by Beneficial Microbes include:
* Worldwide safety and regulatory issues
* Human and animal nutrition and health effects
* Latest discoveries in mechanistic studies and screening methods to unravel mode of action
* Host physiology related to allergy, inflammation, obesity, etc.
* Trends in application of (meta)genomics, proteomics and metabolomics
* New developments in how processing optimizes pro- & prebiotics for application
* Bacterial physiology related to health benefits