Characterisation of the Gut Microbiota in Term Infants After Maternal Prenatal and Postnatal Supplementation of Probiotics - an Open Label Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Recovery of study product in infant feces
研究概览
简要总结
A monocenter, open label pilot study in pregnant women and their offspring with at least four weeks prenatal and four weeks postnatal maternal intervention with a study product consisting of four different food constituents.
The study will investigate the effect of maternal supplementation with the food constituents on the recovery of the constituents in the maternal and infant feces, the microbiota in both mother and infant and potential transmission routes from mother to infant.
详细描述
Pregnant women will be recruited at the ordinary midwife visit in gestational week 28. The intervention will begin in gestational week 33+0 to ensure at least four weeks prenatal intervention before expected birth.
The study will be conducted in four phases. First phase is the run-in phase. The second phase is the prenatal intervention period from gestational week 33+0 until birth. Third phase is the postnatal intervention period, from birth until four weeks postnatal. The last phase is a two weeks follow-up period without any intake of the investigational product.
Infant stool samples, as well as maternal breast milk samples, stool and urine samples and samples from vagina will be collected on multiple occasions during the study. In addition, sample from placenta, umbilical cord, umbilical cord blood and amnion fluid will be collected. Mothers will be asked to complete electronic questionnaires daily during the course of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant women:
- •Enrolled at Aarhus University Hospital
- •Singleton pregnancy
- •Age above 18 years at informed consent
- •Aim to give birth vaginally
- •Aim to breastfeed
- •No use of probiotics (contained in dietary supplements/ food) after written consent.
- •Gestational age between 37-42 weeks
排除标准
- •Pregnant women • Use of immunosuppressant drugs.
结局指标
主要结局
Recovery of study product in infant feces
时间窗: 28 days after birth
Presence of at least one of the probiotic strains in infant feces using PCR
次要结局
- Recovery of study product in maternal feces(28 days)
- Quantification of the microbiota in breastmilk(28 days after birth)
- Quantification of the maternal vaginal microbiota(28 days)