Chronic stress is a risk-factor for the development of mood and stress-related disorders. Clinical evidence indicates that probiotics can influence the stress response and mood. The Sisu study investigated whether Lacticaseibacillus paracasei Lpc-37® (Lpc-37®) could modulate stress, mood and well-being. Prior to a two-week run-in period, 120 healthy adults (18-45 y) were stratified for sex and chronic stress and randomized to either 1.75 × 10¹⁰ colony forming units (CFU) of Lpc-37 or placebo (1:1) per day for 5 weeks. The primary objective was the effect of Lpc-37 on heart rate (HR) in response to the Trier Social Stress Test (TSST). Secondary objectives were assessed by biomarkers and self-report scales over the study. The primary hypothesis was not met in either the Intention-to-Treat (ITT) or Per Protocol (PP) population, but Lpc-37 reduced the increase in HR in participants with low chronic stress (LCS) and increased HR in participants with high chronic stress (HCS) during the TSST. Supporting significant efficacy in the PP population (n = 113), Lpc-37 reduced perceived stress following intervention. More significant effects were identified within the subgroups where Lpc-37 reduced exhaustion during the TSST and normalized cortisol levels at 8pm in participants with LCS, reduced perceived stress also in females, and increased perceived health and sleep-related recovery in participants with HCS. Adverse events (AEs) were similar between groups, there were no severe AEs, and vital signs remained unchanged. Overall, Lpc-37 reduced perceived stress compared to placebo. Other beneficial effects within biomarkers related to stress indicate that the effects of Lpc-37 may be differentially dependent on sex and chronic stress. (ClinicalTrials.gov: NCT03494725).

慢性压力是情绪和压力相关疾病发生的危险因素。临床证据表明，益生菌可以影响压力反应和情绪。 Sisu 研究调查了副干酪乳杆菌Lpc-37® (Lpc-37®) 是否可以调节压力、情绪和幸福感。在为期两周的磨合期之前，对 120 名健康成年人（18-45 岁）进行性别和慢性应激分层，并随机分配至 1.75 × 10 ¹⁰菌落形成单位 (CFU) 的 Lpc-37 或安慰剂组（1: 1) 每天一次，持续 5 周。主要目标是 Lpc-37 对特里尔社会压力测试 (TSST) 反应中心率 (HR) 的影响。次要目标通过研究中的生物标志物和自我报告量表进行评估。主要假设在意向治疗 (ITT) 或按方案 (PP) 人群中均未得到满足，但 Lpc-37 降低了低慢性压力 (LCS) 参与者的心率增加，并增加了高慢性压力参与者的心率。 TSST 期间的慢性应激 (HCS)。 Lpc-37 降低了干预后的感知压力，支持对 PP 人群 (n = 113) 的显着疗效。在亚组中发现了更显着的效果，其中 Lpc-37 减少了 LCS 参与者在 TSST 期间的疲惫，并使晚上 8 点的皮质醇水平正常化，减少了女性的感知压力，并增加了 HCS 参与者的感知健康和睡眠相关的恢复。各组之间的不良事件（AE）相似，没有严重的 AE，生命体征保持不变。总体而言，与安慰剂相比，Lpc-37 减少了感知压力。与压力相关的生物标志物中的其他有益作用表明，Lpc-37 的作用可能不同程度地依赖于性别和慢性压力。 （ClinicalTrials.gov：NCT03494725）。