Impact of Breast Milk miRNAs on the Infant Gut Microbiota
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Explore the effect of breast milk on the composition of fecal miRNAs in infants
研究概览
简要总结
The first 1000 days of life are a critical period for future health. A healthy gut microbiota (GM) is essential for preventing both short-term and long-term health issues. Breast milk (BM) plays a key role in establishing the GM, as, unlike formula milk, it contains miRNAs that may interact with and modulate the microbiota.
Primary Objective: To study the effect of BM on the composition of fecal miRNAs in exclusively breastfed infants compared to those fed with formula milk at different times (D10, D30, D60, M6, M12).
Secondary Objectives:
Analyze the effect of BM miRNAs on infant fecal microbiota, taking environmental confounding factors into account.
Study the influence of BM microbiota on miRNA profiles in the milk. Examine the effect of BM microbiota on the infants' gut microbiota. Explore the links between BM miRNAs, infant gut microbiota, and intestinal inflammation.
详细描述
The first 1,000 days of life are a critical period that significantly contributes to the programming of an individual's health. It is increasingly evident that establishing a healthy gut microbiota (GM) plays an important role in preventing both short- and long-term health issues.
Among the factors influencing the establishment of the infant's gut microbiota, breast milk (BM) plays a fundamental role. Unlike formula milk, breast milk contains miRNAs that are potential mediators of the interactions between the host and the microbiota. Thus, we hypothesize that miRNAs from breast milk may be present in the infant's luminal content and interact with their microbiota, thereby modulating it.
Main Objective: Explore the effect of breast milk on the composition of fecal miRNAs in infants.
Primary Evaluation Criterion: Profiles and quantities of miRNAs at different time points (D10, D30, D60, M6, and M12) in the stools of exclusively breastfed infants compared to those fed with formula milk.
Secondary Objectives:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant women in the 3rd trimester of pregnancy (3T) with a normal course of pregnancy up to 39 weeks consulting for the monitoring visit at the Robert-Debré hospital.
- •Patients who did not receive antibiotic treatment or probiotics in 3T.
- •Patient with a negative PV for Strepto B
- •Patients who do not have complications such as pre-eclampsia or gestational diabetes.
- •Breastfeeding (+/- milk pump) or exclusive artificial breastfeeding.
- •No opposition from the mother
- •Ability to master the French language required.
- •Freezer at home.
- •Affiliation to a social security scheme.
排除标准
- •Cesarean delivery
- •Perinatal pathologies (Anoxia, IUGR, etc.)
- •Neonatal pathologies (FGR, malformations, etc.)
- •Initial choice of mixed breastfeeding
- •Patient under AME (State Medical Aid)Critères d'exclusions :
- •Antibiotics for the mother or child before day 60
- •Antifungal for the mother or child before day 60
- •Complete cessation of breastfeeding before day 60
结局指标
主要结局
Explore the effect of breast milk on the composition of fecal miRNAs in infants
时间窗: 12 months
profiles and quantities of miRNAs at different times (D10, D30, D60, M6, and M12) in the stools of exclusively breastfed infants compared to those fed with formula milk
次要结局
未报告次要终点