Sami-Sabinsa Group Limited, Bangalore, Karnataka, India.
Sabinsa Corporation, East Windsor, NJ.
Medicine (Baltimore). 2023 May 19;102(20):e33751. doi: 10.1097/MD.0000000000033751.
Probiotics are known to rebalance the gut microbiota in dysbiotic individuals, but their impact on the gut microbiome of healthy individuals is seldom studied. The current study is designed to assess the impact and safety of Bacillus coagulans (Weizmannia coagulans) microbial type culture collection 5856 (LactoSpore®) supplementation on microbiota composition in healthy Indian adults.
The study participants (N = 30) received either LactoSpore (2 billion colony-forming units/capsule) or placebo for 28 days. The general and digestive health were assessed through questionnaires and safety by monitoring adverse events. Taxonomic profiling of the fecal samples was carried out by 16S rRNA amplicon sequencing using the Illumina MiSeq platform. The bacterial persistence was enumerated by quantitative reverse transcription-polymerase chain reaction.
Gut health, general health, and blood biochemical parameters remained normal in all the participants. No adverse events were reported during the study. Metataxonomic analysis revealed minimal changes to the gut microbiome of otherwise healthy subjects and balance of Bacteroidetes and Firmicutes was maintained by LactoSpore. The relative abundance of beneficial bacteria like Prevotella, Faecalibacterium, Blautia, Megasphaera, and Ruminococcus showed an increase in probiotic-supplemented individuals. The quantitative polymerase chain reaction analysis revealed highly variable numbers of B. coagulans in feces before and after the study.
The present study results suggest that LactoSpore is safe for consumption and does not alter the gut microbiome of healthy individuals. Minor changes in a few bacterial species may have a beneficial outcome in healthy individuals. The results reiterate the safety of B. coagulans microbial type culture collection 5856 as a dietary supplement and provide a rationale to explore its effect on gut microbiome composition in individuals with dysbiosis.
益生菌已知可使失调个体的肠道微生物群落重新达到平衡，但它们对健康个体肠道微生物组的影响很少被研究。本研究旨在评估凝结芽孢杆菌（凝结魏斯氏菌）微生物型培养物集 5856（LactoSpore®）补充剂对健康印度成年人肠道微生物群落组成的影响和安全性。
研究参与者（N=30）接受 LactoSpore（20 亿个菌落形成单位/胶囊）或安慰剂治疗 28 天。通过问卷调查评估一般和消化健康，通过监测不良事件评估安全性。使用 Illumina MiSeq 平台通过 16S rRNA 扩增子测序进行粪便样本的分类分析。通过定量逆转录聚合酶链反应计数细菌持久性。
所有参与者的肠道健康、一般健康和血液生化参数均保持正常。研究过程中未报告不良事件。元分类分析显示，健康受试者的肠道微生物组发生了微小变化，LactoSpore 维持了拟杆菌门和厚壁菌门之间的平衡。益生菌补充剂组中有益细菌如Prevotella、Faecalibacterium、Blautia、Megasphaera 和 Ruminococcus 的相对丰度增加。聚合酶链反应分析显示，研究前后粪便中 B. coagulans 的数量高度可变。
本研究结果表明，LactoSpore 可安全食用，不会改变健康个体的肠道微生物组。少数细菌种类的微小变化可能对健康个体有益。这些结果重申了凝结芽孢杆菌微生物型培养物集 5856 作为膳食补充剂的安全性，并为探索其在肠道菌群失调个体肠道微生物群落组成中的作用提供了依据。
