Vaginal microbiome seeding and health outcomes in Cesarean-delivered neonates: a randomized controlled trial

剖腹产新生儿的阴道微生物群播种和健康结果：一项随机对照试验

• 批准号: 10927996
• 负责人: Suchitra Hourigan
• 金额: $ 167.3万
• 依托单位: NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10927996
• 关键词: 2 year old; 3 year old; Adverse event; Animal Model; Birth; Body mass index; COVID-19; Cesarean section; Child Health; Clinical; Clinical Research; Clinical Trials; Data; Data Collection; Development; Disease; Electronic Health Record; Engraftment; Enrollment; Exposure to; Feces; Health; Health protection; Immune; Immune System Diseases; Infant; Inflammatory; Intervention; Life; Link; Mediating; Metabolic; Metabolic Diseases; Methods; Microbe; Mothers; Newborn Infant; Obesity; Operative Surgical Procedures; Oral cavity; Outcome; Outcome Measure; Persons; Pilot Projects; Procedures; Randomized; Randomized, Controlled Trials; Regulation; Research Personnel; Safety; Site; Skin; Structure; Surveys; Swab; Testing; Vagina; Visit; arm; beneficial microorganism; experimental arm; follow-up; gut microbiota; health of the mother; high risk; immune health; insight; maternal microbiome; microbiome; microbiome analysis; neonate; normal microbiota; obesity risk; offspring; phase 1 study; phase 2 study; primary outcome; restoration; sample collection; secondary outcome; skin microbiota; treatment arm; vaginal microbiome; vaginal microbiota

During the Fiscal Year 2023, the clinical trial continued enrollment after a 2 year pause due to Covid-19. Many mothers have been enrolled and randomized, with infants being followed up to 3 years of age with serial data and sample collection points. Initial early life microbiome data between treatment arms has been analyzed and shows a difference in microbiome structure and composition between treatment arms and that vaginal seeding causes engraftment of the maternal microbiome in multiple infant body sites. Animal models of vaginal seeding to gain further mechanistic insight have commenced.

在2023财年，临床试验在因新冠肺炎暂停2年后继续招募。许多母亲已经登记并被随机分组，婴儿被跟踪到3岁以下，并使用系列数据和样本采集点进行跟踪。对治疗臂之间最初的早期生命微生物组数据进行了分析，结果表明，治疗臂之间在微生物组结构和组成上存在差异，阴道播种导致母亲的微生物组植入多个婴儿身体部位。阴道播种的动物模型已经开始，以获得进一步的机械洞察。