Exploration of Breast Milk by Culture Through "Microbial Culturomics" and by Targeted Metagenomics Through 16S Ribosomal RNA Gene Sequencing. Influence on the Development of Early and Late Neonatal Sepsis in Infants Under Three Months of Age.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Description of bacterial carriage of breast milk
研究概览
简要总结
Breast milk contains many microorganisms including bacteria that are beneficial to health (probiotics), but also bacteria that are generally considered pathogenic.
Several studies have described an increased risk of infections due to pathogenic germs in breast milk in premature newborns whose digestive system is immature and whose digestive flora is modified by repeated antibiotic treatments.
However, a breastfed baby is better protected against infectious diseases than a bottle-fed baby. The objective of this study is to define the breast milk microbiota of infants with confirmed early or late neonatal bacterial infection compared to the breast milk microbiota of infants with no evidence of bacterial infection. For that purpose, an exploration will be performed using the principle of "Microbial Culturomics" and targeted metagenomics (16S ribosomal RNA gene sequencing).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Breastfeeding mothers of infants:
- •Aged 1 to 89 days consulting in hospitals in the Marseille area (Assistance Publique des Hôpitaux de Marseille: Hôpital de la Timone-enfants and Hôpital Nord),
- •Suspected neonatal bacterial infection due to the presence of fever (rectal or axillary temperature > 38°C),
- •In whom bacteriological samples have been taken (cerebrospinal fluid, joint fluid, blood cultures, urine),
- •Patients affiliated or benefiting from a social security system.
排除标准
- •Exclusive formula milk feeding
- •Opposition of legal guardians
- •No bacteriological sample to prove infant infection
- •No confirmation of fever by standardized method
- •Opposition to participating in the study
- •Neonatal hospitalization > 48 hours for management of prematurity.
- •Severe congenital malformations in the infant.
- •Antibiotic treatment for a concomitant bacterial infection in the infant.
研究组 & 干预措施
Breastfeeding mother
Breastfeeding mother with infants between 1 and 89 days of age who presented with suspected neonatal bacterial sepsis due to the presence of a fever.
干预措施: Collection of breast milk (Other)
结局指标
主要结局
Description of bacterial carriage of breast milk
时间窗: 18 months
Identify the bacterial carriage of breast milk of infants with neonatal sepsis. Microbial anlaysis of mother's milk from baby with neonatal sepsis.
次要结局
- Comparison of breast milk of infants with neonatal sepsis to infants without neonatal sepsis.(18 months)
- Comparison of milk germs to children's germs.(18 months)
- Comparison of microbiota profiles in breast milk(18 months)