Recovery of a Probiotic in Term Newborns - a Randomized, Double-blinded, Placebo-controlled Proof-of-concept Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Recovery of the probiotic strain in newborn/infant fecal samples
研究概览
简要总结
The BABIES study is a single-center, randomized, double-blinded, placebo-controlled study in newborns with a 4-week intervention period from birth to 28 days of life followed by a 2-week follow-up period (Figure 1). The study will evaluate the seeding ability of supplementation with a probiotic strain.
The aim is to investigate the recovery and engraftment of the probiotic strain in infant fecal samples after 4 weeks supplementation using a strain specific quantitative Polymerase Chain Reaction (qPCR).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Participant, Care Provider, Investigator, Outcomes Assessor
入排标准
- 年龄范围
- — 至 1 Day（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion Criteria for the pregnant person:
- •Healthy pregnant person in gestational week 36+0-38+0
- •Age ≥ 18 years
- •Normal singleton pregnancy
- •Ability to read and speak Danish
- •Normal ultrasound scan of the fetus at gestational age 19-20 weeks
- •Plan to exclusively breastfeed
- •Provided voluntary written informed consent.
- •Inclusions Criteria for the newborn:
- •Born at full-term ≥37+0
- •Birth weight above 2500 g
- •APGAR score of at least 7 within the first 5 min of life.
排除标准
- •Exclusion Criteria for the pregnant person:
- •Pregnancy at over 38+0 weeks' gestation at recruitment
- •Multiple pregnancy
- •Pregnancy with any fetal abnormality
- •Alcohol or drug abuse
- •Plan to give birth at other hospitals than Copenhagen University Hospital Hvidovre
- •Any contraindications for breastfeeding.
- •Exclusion Criteria for the newborn :
- •Congenital disorders that could affect their safety or the study outcome
- •Admission to Neonatal Intensive Care Unit for more than 24 hours
- •Participation in another clinical intervention study which can interfere with this probiotic intervention
- •No other probiotics than the study product.
结局指标
主要结局
Recovery of the probiotic strain in newborn/infant fecal samples
时间窗: Birth (first stool after meconium), 2 weeks, 4 weeks, and 6 weeks
Abundance of the probiotic strain in newborn/infant fecal samples measured by quantitative PCR.
次要结局
- Infant fecal pH(Birth (first stool after meconium), 2 weeks, 4 weeks, and 6 weeks)
- Total abundance of bifidobacteria(Birth (first stool after meconium), 2 weeks, 4 weeks, and 6 weeks)
- Infant fecal short chain fatty acids (SCFA)(Birth (first stool after meconium), 2 weeks, 4 weeks, and 6 weeks)
研究者
Andreas Munk Petersen
Professor Andreas Munk Petersen, MD, PhD, DMSc
Hvidovre University Hospital