背景:微生物群组成对人类健康至关重要,肠道微生物群在生命的头两年内发生了重大变化。发育中的肠道微生物群是由母体播种形成的,母乳及其复杂成分,其他营养素,和环境。了解依赖微生物群的病理需要对健康婴儿微生物群的早期发育有深刻的理解。
方法:将在伯尔尼大地区的250名健康孕妇(妊娠≥20周)纳入伯尔尼大学医院的产科。参与者在分娩时将被跟踪为母婴对,出生后第1、2、6、10、14、24、36、48、96周以及第5年和第10周。描述婴儿生长发育的临床参数,发病率,过敏状况以及社会经济状况,营养,和流行病学数据将被记录在案。神经发育结果和行为将通过2岁及以上的儿童行为清单进行评估。产妇大便,牛奶,皮肤和阴道拭子,婴儿大便,在登记和随访时将收集皮肤拭子。对于主要结果,婴儿肠道微生物群的轨迹将通过16S和宏基因组测序来表征,代谢潜力,和稳定在生命的头2年。次要结果将评估母乳的细胞和化学成分,营养和环境对微生物群发育的影响,在阴道或剖腹产时以及婴儿之后的母体微生物组转移,以及微生物群和母乳对婴儿生长的相关参数,发展,健康,和心理健康。
结论:伯尔尼出生队列研究将提供高资源环境中微生物群成熟轨迹的详细描述和正常范围。这些数据将与来自低资源环境的数据进行比较,例如来自津巴布韦-健康科学学院-出生队列研究。前瞻性生物采样和数据收集将允许研究微生物群与常见儿童过敏状况的关联。肥胖,神经发育结果,和行为。试验登记试验已在www上登记。
结果:政府,标识符:NCT04447742。
Microbiota composition is fundamental to human health with the intestinal microbiota undergoing critical changes within the first two years of life. The developing intestinal microbiota is shaped by maternal seeding, breast milk and its complex constituents, other nutrients, and the environment. Understanding microbiota-dependent pathologies requires a profound understanding of the early development of the healthy infant microbiota.
Two hundred and fifty healthy pregnant women (≥20 weeks of gestation) from the greater Bern area will be enrolled at Bern University hospital\'s maternity department. Participants will be followed as mother-baby pairs at delivery, week(s) 1, 2, 6, 10, 14, 24, 36, 48, 96, and at years 5 and 10 after birth. Clinical parameters describing infant growth and development, morbidity, and allergic conditions as well as socio-economic, nutritional, and epidemiological data will be documented. Neuro-developmental outcomes and behavior will be assessed by child behavior checklists at and beyond 2 years of age. Maternal stool, milk, skin and vaginal swabs, infant stool, and skin swabs will be collected at enrolment and at follow-up visits. For the primary outcome, the trajectory of the infant intestinal microbiota will be characterized by 16S and metagenomic sequencing regarding composition, metabolic potential, and stability during the first 2 years of life. Secondary outcomes will assess the cellular and chemical composition of maternal milk, the impact of nutrition and environment on microbiota development, the maternal microbiome transfer at vaginal or caesarean birth and thereafter on the infant, and correlate parameters of microbiota and maternal milk on infant growth, development, health, and mental well-being.
The Bern birth cohort
study will provide a detailed description and normal ranges of the trajectory of microbiota maturation in a high-resource setting. These data will be compared to data from low-resource settings such as from the Zimbabwe-College of Health-Sciences-Birth-Cohort
study. Prospective bio-sampling and data collection will allow studying the association of the microbiota with common childhood conditions concerning allergies, obesity, neuro-developmental outcomes , and behaviour.
Trial registration The
trial has been registered at www.
gov , Identifier: NCT04447742.