Dong Yao, Cai Yihui, Tian Hairui, Wen Jian, Han Mei, Tan Yan, Zou Kang
Germline Stem Cells and Microenvironment Lab, College of Animal Science and Technology, Nanjing Agricultural University, Nanjing, 210095, China; Stem Cell Research and Translation Center, Nanjing Agricultural University, Nanjing, 210095, China.
Biomedical Engineering College, Hubei University of Medicine, Shiyan 442000, China.
Clin Nutr. 2025 Aug;51:349-361. doi: 10.1016/j.clnu.2025.07.004. Epub 2025 Jul 7.
This study aims to evaluate the physiological and psychological health impacts of Bifidobacterium breve BBr60 (BBr60) on healthy adults.
The study was divided into preclinical research and a clinical trial phase. In the preclinical study, the bioactive components of BBr60 were analyzed through LC-MS targeted metabolomics. In the clinical trial, 109 healthy adults aged 19-45 were recruited to participate in an 8-week double-blind, randomized, placebo-controlled study. Participants were randomly assigned to receive either a BBr60 supplement (10 CFU/day) or a placebo (maltodextrin). Throughout the study, liver function, metabolic markers, cardiovascular and body composition metrics were assessed. Volunteer scores on the Alcohol Dependence Scale (ADS), Nepean Dyspepsia Index (NDI), Gastrointestinal Symptom Scale (GIS), and Positive and Negative Affect Schedule (PANAS) were recorded, and the impact on the intestinal microbiota structure and function of healthy participants was analyzed through 16S rRNA sequencing.
The preclinical study indicated the role of BBr60 in modulating key metabolic pathways, including those involved in ABC transporters, arginine, proline, and tryptophan metabolism. Clinical trial results demonstrated significant improvements in high-density lipoprotein (HDL) levels and reductions in total cholesterol with BBr60 supplementation. Gastrointestinal symptoms and emotional states also improved, with significant reductions in ADS scores (p = 0.000), particularly in symptoms related to alcohol consumption such as post-drinking memory loss and tremulous delirium. Additionally, significant enhancements in gastrointestinal health were observed, as indicated by a notable decrease in NDI scores (p = 0.002), suggesting reduced impact of stomach issues on daily life. GIS scores further confirmed improvements in gastrointestinal function, particularly in early satiety and appetite. While overall emotional changes were not significant, positive emotional scores increased post-intervention, and negative emotional scores decreased. The probiotic demonstrated good safety and tolerability throughout the 8-week trial period.
Supplementation with BBr60 not only significantly alleviated neuropsychiatric symptoms associated with alcohol consumption but also showed potential benefits in enhancing gastrointestinal and metabolic health. These findings support further research into BBr60 as a potential non-pharmacological intervention to improve both psychological and physiological health.
NCT06196892 (ClinicalTrials.gov).
本研究旨在评估短双歧杆菌BBr60（BBr60）对健康成年人身心健康的影响。
该研究分为临床前研究和临床试验阶段。在临床前研究中，通过液相色谱-质谱靶向代谢组学分析BBr60的生物活性成分。在临床试验中，招募了109名年龄在19至45岁之间的健康成年人，参与一项为期8周的双盲、随机、安慰剂对照研究。参与者被随机分配接受BBr60补充剂（10 CFU/天）或安慰剂（麦芽糊精）。在整个研究过程中，评估肝功能、代谢指标、心血管和身体成分指标。记录志愿者在酒精依赖量表（ADS）、内皮消化不良指数（NDI）、胃肠道症状量表（GIS）以及正负情绪量表（PANAS）上的得分，并通过16S rRNA测序分析对健康参与者肠道微生物群结构和功能的影响。
临床前研究表明BBr60在调节关键代谢途径中发挥作用，包括那些参与ABC转运蛋白、精氨酸、脯氨酸和色氨酸代谢的途径。临床试验结果显示，补充BBr60可使高密度脂蛋白（HDL）水平显著提高，总胆固醇降低。胃肠道症状和情绪状态也有所改善，ADS得分显著降低（p = 0.000），尤其是与饮酒相关的症状，如酒后失忆和震颤谵妄。此外，观察到胃肠道健康有显著改善，NDI得分显著下降（p = 0.002），表明胃部问题对日常生活的影响减小。GIS得分进一步证实了胃肠道功能的改善，特别是早饱感和食欲方面。虽然总体情绪变化不显著，但干预后积极情绪得分增加，消极情绪得分降低。在为期8周的试验期内，该益生菌显示出良好的安全性和耐受性。
补充BBr60不仅能显著缓解与饮酒相关的神经精神症状，还在增强胃肠道和代谢健康方面显示出潜在益处。这些发现支持进一步研究BBr60作为一种潜在的非药物干预措施，以改善心理和生理健康。
NCT06196892（ClinicalTrials.gov）。
