Nutrition and Metabolism, NOVA Medical School | Faculdade de Ciências Médicas, Universidade NOVA de Lisboa, Lisbon, Portugal.
CINTESIS - Center for Health Technology and Services Research, Porto, Portugal.
BMJ Open. 2019 Nov 24;9(11):e028916. doi: 10.1136/bmjopen-2019-028916.
The gut microbiota plays a main role in the maintenance of host's health. Exposure to different conditions in early life contributes to distinct 'pioneer' bacterial communities in the intestine, which shape the newborn infant development. Newborn infants with congenital malformations of the gastrointestinal tract (CMGIT), necrotising enterocolitis (NEC) and spontaneous intestinal perforation (SIP) commonly require abdominal surgery and enterostomy. The knowledge about the colonisation of these newborns' intestine by microorganisms is scarce. This protocol is designed to explore the microbial colonisation over time of the proximal intestinal remnant in newborn infants who underwent surgery for CMGIT, NEC or SIP and require enterostomy.
The literature about microbiota colonisation in newborn infants with enterostomy was reviewed and an observational, longitudinal, prospective study was designed. The infants will be recruited at the Neonatal Intensive Care Unit of the Hospital Dona Estefânia, Centro Hospitalar Universitário de Lisboa Central. Samples of the enterostomy effluent will be collected every 3 days, through 21 days after the first collection. The microorganisms colonising the proximal intestinal remnant will be identified using the 16S rRNA sequence analysis and a subset of microorganisms will be quantified using real-time PCR. This protocol may serve as basis for future observational and interventional studies on the modulation of the intestinal microbiota (eg, probiotics) on short and long-term outcomes in this population.
This study protocol was approved by the Ethics Committee of Centro Hospitalar Universitário de Lisboa Central (441/2017) and by the Ethics Committee of NOVA Medical School, Universidade Nova de Lisboa (n°50/2018/CEFCM). The results will be spread through peer-reviewed publications and presentations at international scientific meetings.
NCT03340259.
肠道微生物群在维持宿主健康方面发挥着主要作用。在生命早期接触不同的环境条件会导致肠道中出现不同的“先驱”细菌群落，从而影响新生儿的发育。患有胃肠道先天性畸形（CMGIT）、坏死性小肠结肠炎（NEC）和自发性肠穿孔（SIP）的新生儿通常需要腹部手术和肠造口术。关于这些新生儿肠道中微生物定植的知识还很缺乏。本方案旨在探讨因 CMGIT、NEC 或 SIP 而行腹部手术和肠造口术的新生儿，其近端肠道残端随时间推移的微生物定植情况。
回顾了关于肠造口新生儿微生物群定植的文献，并设计了一项观察性、纵向、前瞻性研究。这些婴儿将在里斯本中心大学医院唐娜埃斯特法尼亚新生儿重症监护病房招募。将通过肠造口排出物每隔 3 天收集一次样本，第一次收集后 21 天内共收集 21 次。使用 16S rRNA 序列分析鉴定定植于近端肠道残端的微生物，并用实时 PCR 定量检测部分微生物。本方案可能为未来在该人群中进行关于肠道微生物群（如益生菌）的短期和长期干预研究提供依据，以改善其短期和长期结局。
本研究方案获得了里斯本中心大学医院伦理委员会（441/2017）和新里斯本诺瓦医科大学伦理委员会（n°50/2018/CEFCM）的批准。结果将通过同行评议的出版物和国际科学会议上的演讲传播。
NCT03340259。
