有早产危险的孕妇补充多株双歧杆菌和乳酸杆菌益生菌后对 HMO 组成的影响:随机临床 PROMO 试验的设计。

IF 2.4 Q1 PEDIATRICS
A Welp, E Laser, K Seeger, A Haiß, K Hanke, K Faust, G Stichtenoth, C Fortmann-Grote, J Pagel, J Rupp, W Göpel, M Gembicki, J L Scharf, A Rody, E Herting, C Härtel, I Fortmann
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引用次数: 0

摘要

背景:人乳低聚糖(HMOs)是母乳中一种不易消化的成分,在新生儿微生物组的建立过程中发挥着重要作用。此外,它们还被证明对免疫系统、肺部和大脑发育有益。对于早产儿来说,母乳中的 HMO 成分可能具有特别重要的意义,因为健康微生物群的建立受到与早产有关的多种干扰因素(如剖腹产、医院环境和围产期抗生素接触)的挑战。之前的一项研究提出,在妊娠晚期补充母体益生菌可能会改变母乳中的 HMO 组成。然而,目前还没有关于早产孕妇的研究。此外,HMO 成分与易感婴儿的临床相关结果(包括败血症、坏死性小肠结肠炎(NEC)或慢性肺部疾病等炎症介导的疾病)之间的关系也未进行过研究:一项随机对照干预研究(PROMO = 母乳低聚糖益生菌)旨在分析有早产风险的孕妇在补充益生菌(嗜酸乳杆菌、乳双歧杆菌和婴儿双歧杆菌)后母乳中 HMO 成分的变化。主要终点是母乳中 3-岩藻糖乳糖和 3'-sialyllactose 的 HMO 成分。根据治疗组和对照组之间的标准化平均差,我们估计益生菌干预将使这两种 HMO 水平提高 50%。作为次要结果,我们将测量早产儿的临床结果(早产、败血症、体重增长、胃肠道并发症),以及通过高分辨率基因组测序对母亲分娩时直肠阴道和足月儿及早产儿肠道微生物组组成的影响。因此,我们将在婴儿出生后 4 周内以及 3 个月、1 岁和 5 岁时的随访调查中纵向收集生物样本:我们估计,根据治疗组和对照组之间的标准化平均差异,益生菌干预将使这两种 HMO 水平提高 50%。PROMO研究将深入了解胎儿与母体界面上微生物组与HMO的相互作用及其对妊娠期和婴儿结局的影响。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Effects of multistrain Bifidobacteria and Lactobacillus probiotics on HMO compositions after supplementation to pregnant women at threatening preterm delivery: design of the randomized clinical PROMO trial.

Background: As an indigestible component of human breast milk, Human Milk Oligosaccharides (HMOs) play an important role as a substrate for the establishing microbiome of the newborn. They have further been shown to have beneficial effects on the immune system, lung and brain development. For preterm infants HMO composition of human breast milk may be of particular relevance since the establishment of a healthy microbiome is challenged by multiple disruptive factors associated with preterm birth, such as cesarean section, hospital environment and perinatal antibiotic exposure. In a previous study it has been proposed that maternal probiotic supplementation during late stages of pregnancy may change the HMO composition in human milk. However, there is currently no study on pregnancies which are threatened to preterm birth. Furthermore, HMO composition has not been investigated in association with clinically relevant outcomes of vulnerable infants including inflammation-mediated diseases such as sepsis, necrotizing enterocolitis (NEC) or chronic lung disease.

Main body: A randomized controlled intervention study (PROMO = probiotics for human milk oligosaccharides) has been designed to analyze changes in HMO composition of human breast milk after supplementation of probiotics (Lactobacillus acidophilus, Bifidobacterium lactis and Bifidobacterium infantis) in pregnancies at risk for preterm birth. The primary endpoint is HMO composition of 3-fucosyllactose and 3'-sialyllactose in expressed breast milk. We estimate that probiotic intervention will increase these two HMO levels by 50% according to the standardized mean difference between treatment and control groups. As secondary outcomes we will measure preterm infants' clinical outcomes (preterm birth, sepsis, weight gain growth, gastrointestinal complications) and effects on microbiome composition in the rectovaginal tract of mothers at delivery and in the gut of term and preterm infants by sequencing at high genomic resolution. Therefore, we will longitudinally collect bio samples in the first 4 weeks after birth as well as in follow-up investigations at 3 months, one year, and five years of age.

Conclusions: We estimate that probiotic intervention will increase these two HMO levels by 50% according to the standardized mean difference between treatment and control groups. The PROMO study will gain insight into the microbiome-HMO interaction at the fetomaternal interface and its consequences for duration of pregnancy and outcome of infants.

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