Characterization of the Gastrointestinal Microbiota in Term Newborn Infants After 4 Weeks 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
- 22
- 试验地点
- 2
- 主要终点
- Recovery of the investigational product in the infant feces
研究概览
简要总结
A mono center, open label, pilot study in term newborn infants. The study will investigate the effect of supplementation with probiotics on the presence of total Bifidobacterium in the infant feces.
详细描述
The four weeks intervention starts within 24 hours after birth of the study subject and the investigational product will be given for 28 days, followed by a two weeks follow-up period without any intake of the investigational product.
During the entire study period, five visits are scheduled. Visit 2 to Visit 5 are home visits by the study midwife. From Visit 2 and throughout the study period (Visit 2 to Visit 5) the parents will be asked to complete a diary daily.
Infant stool samples will be collected on multiple occasions during the study, as well as maternal breast milk samples, stool and urine samples and samples from vagina. 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
- 0 Days 至 2 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Infants to be enrolled at birth.
- •Inclusion Criteria for Infants (study subjects)
- •Gestational age at birth ≥ 37±0 ≤ weeks 42±0 weeks
- •Birthweight more than 2500 g
- •No exposure to oral or intravenous antibiotics
- •No complications that need medical interventions (e.g. respiratory distress symptoms or infections)
- •Both legal guardians provided voluntary written informed consent on behalf of the infant
- •Pregnant women:
- •Women age above 18 years at informed consent
- •Singleton pregnancy
- •Uncomplicated pregnancy
- •No use of medication
- •Aim to give birth vaginally and breastfeed
- •No use of probiotics during the last month before estimated birth and until six weeks postpartum
- •Provided voluntary written informed consent
排除标准
- •for Infants (study subjects)
- •Admission to the neonatal intensive care unit (NICU)
结局指标
主要结局
Recovery of the investigational product in the infant feces
时间窗: 28 days after birth
Presence of the investigational product in infant fecal samples after 4 weeks of supplementation (Visit 4) using PCR
次要结局
- Total fecal Bifidobacterium in infant fecal samples(Baseline, Day14, Day 28)
- Characterization of the infant intestinal microbiota after 4 weeks supplementation(Baseline, Day 14, Day 28)
- Adverse events (Safety)(up to 6 weeks)