"Intestinal Microbiota Composition After Antibiotic Treatment in Early Life. The INCA Study"
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 450
- 试验地点
- 4
- 主要终点
- Clinical endpoints
研究概览
简要总结
In this prospective observational cohort study the potential clinical consequences of antibiotic use in early life and perturbations in the gastrointestinal microbiota composition due to that antibiotic use are studied. It is hypothesized that altered microbiota may be an important underlying mechanism for impediments in the developing immune system.
Differentiation will be made between a group of neonates who received antibiotics in the first week of life, and control infants who were not exposed to antibiotics in the neonatal period.
详细描述
Healthy newborns born in the hospital, observed for low probability of neonatal infection will be compared to newborns exposed to antibiotic therapy in early life (first 1-2 weeks).
Infants are recruited from the maternity wards and neonatal wards of four teaching hospitals in the Netherlands. In total 150 infants, treated with antibiotics because of (a high suspicion of) a perinatal infection during the first week of life, will be recruited. The control group comprises 300 healthy newborns, born in the hospital and needing clinical observation for 24-48 hours for several reasons like maternal comorbidity, low probability of neonatal infection, blood sugar monitoring, meconium containing amniotic fluid, or delivery by caesarean section.
Differences in clinical outcomes between antibiotic treated infants and controls are investigated. Incidence of atopic dermatitis (eczema), food allergy, upper respiratory tract infections (URTI), lower respiratory tract infections (LRTI), gastrointestinal infections (GITI) and excessive crying are evaluated, prospectively assessed by parental reports and retrospectively assessed by doctor's diagnoses. The clinical endpoints will be linked to the developing intestinal microbiota during the first year of life.
Potential differences in intestinal fecal microbiota composition and diversity can be determined at eight time points during the first year of life, as sampling moments include: day one (T1), day two (T2), one week (T3), two weeks (T4), one month (T5), three months (T6), six months (T7), one year (T8).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Hour 至 7 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Term-born babies (≥ 36 weeks gestational age)
- •(Short) stay on maternal ward or admission to neonatal ward because of antibiotic treatment
- •Signed informed consent by the parents
排除标准
- •Congenital illness or malformations
- •Severe perinatal infections for which transfer to the neonatal intensive care unit is needed
- •Maternal probiotic use ≤ six weeks before delivery
- •Insufficient knowledge of the Dutch language.
结局指标
主要结局
Clinical endpoints
时间窗: Participants will be followed during their first year of life
Differences in clinical outcomes between antibiotic treated infants and controls are investigated. Incidence of atopic dermatitis (eczema), food allergy, upper respiratory tract infections (URTI), lower respiratory tract infections (LRTI), gastrointestinal infections (GITI) and excessive crying are evaluated. Data are prospectively assessed by parental reports (calendar lists).
次要结局
- Microbiota composition(Samples will be taken at eight time points during the participant's first year of life)
- Vaccine response(around 1 year of age)
- Doctor's diagnosis(Participants will be followed during their first year of life)
研究者
Nicole B.M.M. Rutten
PhD candidate
Agentschap NL