Abdullahi Abdihafid Mohamed, Zhao Shuangkui, Xu Yanping
Department of NICU, Children's Hospital, Zhejiang University School of Medicine, Hangzhou, China.
J Matern Fetal Neonatal Med. 2025 Dec;38(1):2485215. doi: 10.1080/14767058.2025.2485215. Epub 2025 Apr 9.
Necrotizing enterocolitis (NEC) is a severe condition in preterm infants, involving intestinal inflammation and bacterial invasion, leading to high morbidity and mortality. Probiotics may reduce NEC by promoting beneficial gut bacteria, but the role of G001 (BBG001) is not well understood. This meta-analysis evaluates the effectiveness of BBG001 versus placebo in preventing NEC, late-onset sepsis, and all-cause mortality in preterm infants.
Following Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, we conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) from 2014 to 2024. Databases searched included PubMed, Cochrane Central Register, MEDLINE, and EMBASE. Inclusion criteria encompassed RCTs involving preterm infants (<37 weeks gestation and/or <2500 g birth weight) receiving enteral probiotics, including BBG001, compared to placebo. Outcomes assessed were incidence of NEC (≥stage II), late-onset sepsis, and all-cause mortality. Data extraction and quality assessment were independently performed.
From 430 identified records, nine studies involving 7180 preterm infants met the inclusion criteria. BBG001 significantly reduced the risk of NEC stage >2 (OR = 0.66; 95% CI [0.47, 0.94], = .02), mortality and morbidity (OR = 0.74; 95% CI [0.62, 0.89], = .001), and sepsis (OR = 0.71; 95% CI [0.53, 0.93], = .01). It also lowered the odds of periventricular leukomalacia (OR = 0.61; 95% CI [0.47, 0.78], < .0001) and intraventricular hemorrhage (OR = 0.48; 95% CI [0.33, 0.69], < .0001). Additionally, BBG001 showed a protective effect against infection-related outcomes, reducing the odds of death attributed to infection (OR = 0.80; 95% CI: 0.65, 0.99; = .04).
Probiotic supplementation with BBG001 appears effective in reducing NEC incidence, bloodstream infections, and infection-related deaths in preterm infants. Despite promising results, variability in study designs necessitates further large-scale RCTs to confirm these findings and establish BBG001's role in neonatal care.
坏死性小肠结肠炎（NEC）是早产儿的一种严重病症，涉及肠道炎症和细菌入侵，导致高发病率和高死亡率。益生菌可能通过促进有益肠道细菌减少NEC，但G001（BBG001）的作用尚不清楚。本荟萃分析评估了BBG001与安慰剂在预防早产儿NEC、晚发性败血症和全因死亡率方面的有效性。
按照系统评价和荟萃分析的首选报告项目（PRISMA）指南，我们对2014年至2024年的随机对照试验（RCT）进行了系统评价和荟萃分析。检索的数据库包括PubMed、Cochrane中心注册库、MEDLINE和EMBASE。纳入标准包括涉及接受肠内益生菌（包括BBG001）的早产儿（孕周<37周和/或出生体重<2500克）与安慰剂比较的RCT。评估的结局为NEC（≥II期）、晚发性败血症和全因死亡率的发生率。数据提取和质量评估独立进行。
从430条识别记录中，9项涉及7180例早产儿的研究符合纳入标准。BBG001显著降低了NEC>2期的风险（OR = 0.66；95%CI[0.47, 0.94]，P = 0.02）、死亡率和发病率（OR = 0.74；95%CI[0.62, 0.89]，P = 0.001）以及败血症（OR = 0.71；95%CI[0.53, 0.93]，P = 0.01）。它还降低了脑室周围白质软化的几率（OR = 0.61；95%CI[0.47, 0.78]，P < 0.0001）和脑室内出血的几率（OR = 0.48；95%CI[0.33, 0.69]，P < 0.0001）。此外，BBG001对感染相关结局显示出保护作用，降低了因感染导致的死亡几率（OR = 0.80；95%CI：0.65, 0.99；P = 0.04）。
补充BBG001益生菌似乎能有效降低早产儿NEC的发生率、血流感染及感染相关死亡。尽管结果令人鼓舞，但研究设计的差异需要进一步的大规模RCT来证实这些发现，并确定BBG001在新生儿护理中的作用。
