Patole Sanjay, Keil Anthony D, Chang Annie, Nathan Elizabeth, Doherty Dorota, Simmer Karen, Esvaran Meera, Conway Patricia
Department of Neonatal Paediatrics, KEM Hospital for Women, Perth, Australia; Centre for Neonatal Research and Education, University of Western Australia, Perth, Australia.
PathWest Laboratory Medicine WA, KEM Hospital for Women, Perth, Australia.
PLoS One. 2014 Mar 3;9(3):e89511. doi: 10.1371/journal.pone.0089511. eCollection 2014.
BACKGROUND: Probiotic supplementation significantly reduces the risk of necrotising enterocolitis (NEC) and all cause mortality in preterm neonates. Independent quality assessment is important before introducing routine probiotic supplementation in this cohort. AIM: To assess product quality, and confirm that Bifidobacterium breve (B. breve) M-16V supplementation will increase fecal B. breve counts without adverse effects. METHODS AND PARTICIPANTS: Strain identity (16S rRNA gene sequencing), viability over 2 year shelf-life were confirmed, and microbial contamination of the product was ruled out. In a controlled trial preterm neonates (Gestation <33 weeks) ready to commence or on feeds for <12 hours were randomly allocated to either B. breve M-16V (3×109 cfu/day) or placebo (dextrin) supplementation until the corrected age 37 weeks. Stool samples were collected before (S1) and after 3 weeks of supplementation (S2) for studying fecal B. breve levels using quantitative PCR (Primary outcome). Secondary outcomes included total fecal bifidobacteria and NEC≥Stage II. Categorical and continuous outcomes were analysed using Chi-square and Mann-Whitney tests, and McNemar and Wilcoxon signed-rank tests for paired comparisons. RESULTS: A total of 159 neonates (Probiotic: 79, Placebo: 80) were enrolled. Maternal and neonatal demographic characteristics were comparable between the groups. The proportion of neonates with detectable B. breve increased significantly post intervention: Placebo: [S1:2/66 (3%), S2: 25/66 (38%), p<0.001] Probiotic: [S1: 29/74 (40%), S2: 67/74 (91%), p<0.001]. Median S1 B. breve counts in both groups were below detection (<4.7 log cells x g(-1)), increasing significantly in S2 for the probiotic group (log 8.6) while remaining <4.7 log in the control group (p<0.001). There were no adverse effects including probiotic sepsis and no deaths. NEC≥Stage II occurred in only 1 neonate (placebo group). CONCLUSION: B. breve M-16V is a suitable probiotic strain for routine use in preterm neonates. TRIAL REGISTRATION: Australia New Zealand Clinical Trial Registry ACTRN 12609000374268.
背景：补充益生菌可显著降低早产儿坏死性小肠结肠炎（NEC）的风险及全因死亡率。在该队列中引入常规益生菌补充剂之前，独立的质量评估很重要。 目的：评估产品质量，并确认补充短双歧杆菌（B. breve）M-16V可增加粪便中短双歧杆菌数量且无不良反应。 方法与参与者：通过16S rRNA基因测序确认菌株身份，确认产品在2年保质期内的活力，并排除产品的微生物污染。在一项对照试验中，将准备开始喂养或喂养<12小时的早产新生儿（孕周<33周）随机分为补充短双歧杆菌M-16V（3×10⁹ cfu/天）组或安慰剂（糊精）组，直至矫正年龄37周。在补充前（S1）和补充3周后（S2）收集粪便样本，使用定量PCR研究粪便中短双歧杆菌水平（主要结局）。次要结局包括粪便中总双歧杆菌和NEC≥II期。分类和连续结局分别采用卡方检验和曼-惠特尼检验进行分析，配对比较采用 McNemar检验和 Wilcoxon符号秩检验。 结果：共纳入159例新生儿（益生菌组：79例，安慰剂组：80例）。两组间母婴人口统计学特征具有可比性。干预后可检测到短双歧杆菌的新生儿比例显著增加：安慰剂组：[S1：2/66（3%），S2：25/66（38%），p<0.001]；益生菌组：[S1：29/74（40%），S2：67/74（91%），p<0.001]。两组S1时短双歧杆菌计数中位数均低于检测下限（<4.7 log细胞×g⁻¹），益生菌组S2时显著增加（log 8.6），而对照组仍<4.7 log（p<0.001）。未出现包括益生菌败血症在内的不良反应，也无死亡病例。仅1例新生儿（安慰剂组）发生NEC≥II期。 结论：短双歧杆菌M-16V是一种适合在早产新生儿中常规使用的益生菌菌株。 试验注册：澳大利亚新西兰临床试验注册中心ACTRN 12609000374268。
J Matern Fetal Neonatal Med. 2020-7
JPEN J Parenter Enteral Nutr. 2017-12-19
Nutrients. 2025-5-29
Pediatr Res. 2025-5-13
Pharmaceuticals (Basel). 2012-6-18
Clin Perinatol. 2013-3
J Hosp Infect. 2013-2-13
J Perinatol. 2013-1
Am J Physiol Gastrointest Liver Physiol. 2012-11-15
Transl Res. 2012-11-9
Gastroenterol Clin North Am. 2012-12
Gastroenterol Clin North Am. 2012-10-5
Ann Nutr Metab. 2012-10-2
Zotero 插件