Abstract：
Group B Streptococcus (GBS) is the leading cause of bacterial neonatal sepsis. This study aimed to confirm the effect of Ligilactobacillus salivarius V4II-90 on GBS colonisation during pregnancy. A randomised, multicentre, double-blind, placebo-controlled, parallel-group study was conducted in seven hospitals in Madrid, Spain. The sample was broken down into two groups with 20 participants each (n = 40) in order to show reduced GBS colonisation frequency in the probiotic versus the placebo group. Pregnant participants positive for vaginal-rectal colonisation before or during the 13th week of gestation were randomly assigned to either the placebo or the probiotic group. The probiotic, L. salivarius V4II-90 at 1 × 109 cfu/day was administered for 12 weeks, starting at week 21-23 of gestation. The primary outcome was the percentage of participants with vaginal and/or rectal GBS colonisation at the end of the intervention period (35 weeks of gestation). Secondary outcomes were changes in the microbial composition of vaginal and rectal exudates; premature delivery; premature rupture of membranes; intrapartum antibiotics; new-borns with early or late-onset GBS sepsis; adverse events (AEs); and GBS test results performed at the hospital at week 35 of gestation. Of the 481 participants included, 44 were vaginal-rectal colonised with GBS and randomised. 43 completed the study (20 in the probiotic group and 23 in the placebo group). After intervention, GBS was eradicated in six participants (27%) from the placebo group and in twelve participants (63%) from the probiotic group ( P = 0.030). None of the 185 AEs reported were identified as possibly, probably, or definitely related to the investigational product. In conclusion, oral administration of L. salivarius V4II-90 is a safe and successful strategy to significantly decrease the rates of GBS colonisation at the end of pregnancy and, therefore, to reduce the exposure of subjects and their infants to intrapartum antibiotic prophylaxis. Trial registered at ClinicalTrials.gov: number NCT03669094.
摘要：
B族链球菌（GBS）是细菌性新生儿败血症的主要原因。本研究旨在证实唾液小杆菌V4II-90对妊娠期GBS定植的影响。一个随机的，多中心,双盲,安慰剂对照,在马德里的七家医院进行了平行组研究，西班牙。将样品分为两组，每组20名参与者（n=40），以显示益生菌组与安慰剂组的GBS定植频率降低。妊娠13周前或期间阴道直肠定植阳性的孕妇被随机分配到安慰剂组或益生菌组。益生菌，唾液乳杆菌V4II-90以1×109cfu/天给药12周，从妊娠21-23周开始。主要结果是干预期（妊娠35周）结束时阴道和/或直肠GBS定植的参与者百分比。次要结局是阴道和直肠分泌物微生物组成的变化；早产；胎膜早破；产时抗生素；新生儿早期或迟发性GBS脓毒症；不良事件（AE）；以及妊娠35周时在医院进行的GBS检测结果。在481名参与者中，44例阴道直肠定植GBS并随机分组。43人完成了研究（益生菌组20人，安慰剂组23人）。干预后,安慰剂组的6名参与者（27％）和益生菌组的12名参与者（63％）根除了GBS（P=0.030）。报告的185例不良事件均未被确定为可能，可能,或者肯定与研究产品有关。总之,口服唾液乳杆菌V4II-90是一种安全和成功的策略，可以显着降低妊娠结束时GBS定植率，因此,减少受试者及其婴儿接受产时抗生素预防的暴露。在ClinicalTrials.gov注册的试验：编号NCT03669094。
