Efficacy of a Probiotic on Gut Health, Immune Maturation, and Well-being in Term Newborns - a Randomized, Double-blinded, Placebo-controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 378
- 试验地点
- 2
- 主要终点
- Total abundance of Bifidobacteria
研究概览
简要总结
The BABIES II study is a single-center, randomized, double-blinded, placebo-controlled study in newborns with an 8½ months intervention period from 14 days of age to 9 months of age followed by a 3-months short-term follow-up period until 1 year of age and a possible long-term follow-up until 18 years of age. The study will evaluate the effect of supplementation with a probiotic strain on different health outcomes.
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
- 0 Days 至 1 Day（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •"Inclusion Criteria"
- •Inclusion Criteria for the pregnant person
- •Pregnant person above 18 years of age in gestational week 36+0-38+0 (at Visit 0)
- •Singleton pregnancy
- •Ability to read and speak Danish
- •Plan to breastfeed
- •Provided voluntary written informed consent.
- •Inclusions Criteria for the newborn
- •Born at full-term ≥37+0
- •Birth weight ≥ 2500 g
- •APGAR score of ≥ 7 within the first 5 min of life.
排除标准
- •" Exclusion Criteria for the pregnant person
- •Pregnancy at 38 weeks + 0 or later at the time of recruitment
- •Pregnancy with significant fetal abnormality at ultrasound scan of the fetus at gestational age 19-20 weeks
- •Alcohol or drug abuse
- •Plan to give birth at other hospitals than Copenhagen University Hospital Hvidovre
- •Pregnant person with 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
- •Probiotics other than the study product.
研究组 & 干预措施
Probiotic
Probiotic Dietary supplement
干预措施: Probiotic (Other)
Placebo
Identical looking placebo consisting of maltodextrin
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Total abundance of Bifidobacteria
时间窗: At 3 months of age
Abundance of Bifidobacteria in infant fecal samples by quantitative PCR
次要结局
- Infant fecal pH(Birth (first stool after meconium), 2 weeks, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 9 months, and 1 year)
- Infant gut microbiome composition(Birth (first stool after meconium), 2 weeks, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 9 months, and 1 year)
- Proportion of infants with hard or very hard stool consistency(4 months, 5 months, 6 months)
研究者
Andreas Munk Petersen
Professor Andreas Munk Petersen, MD, PhD, DMSc
Hvidovre University Hospital