Infant Supplementation With Probiotic Bifidobacterium Longum Subsp. Infantis Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Infant fecal Bifidobacterium
研究概览
简要总结
The purpose of this study is to determine if supplementing healthy term infants delivered by C-section or vaginal delivery who only consume breastmilk with a probiotic for 21 consecutive days increases levels of bacteria in infants' stool.
详细描述
The purpose of this clinical trial is to determine the effects of supplementing the probiotic Bifidobacterium longum subsp. infantis for the first 21 days of life in healthy term breastfed infants delivered via C-section or vaginal delivery on gut bacteria composition during, 1 week, and 1 month after supplementation compared with matched-control term infants receiving standard care. The investigators' specific aim is to compare the fecal microbiota (total B. infantis, total Bifidobacterium, total bacteria and composition of microbiota) between the supplement and control groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy, non-smoking women and their infants
- •Who are pregnant in their third trimester OR have delivered by C-section or vaginal birth within the past 7 days
- •Patients who live within a 20-mile radius from University of California Davis Medical Center (UCDMC) or a 20-mile radius from UC Davis Campus in Davis, California.
- •Plan to exclusively breastfeed their infants for at least 3 months
- •Infants: 0-7 days old, delivered by C-section or vaginal delivery, born >37 weeks gestation, without medical complications that would preclude breastfeeding or alter gut microbiota
排除标准
- •Infants born with medical complications such as: respiratory distress syndrome, birth defects, and infection
- •Infants who have taken antibiotics for more than 72 hours of life
- •Infants who have consume formula feedings after day 7 of life
- •Mothers and their infants who are not discharged from the hospital by day 4 of life due to complications
- •Plan to administer probiotics to infants or use of probiotics other than the study supplement by infants anytime throughout the study duration
- •Women who have had any breast surgery or injury within the past 5 years that would reduce the chance of successful exclusive breastfeeding
- •Mothers who have a chronic metabolic disease or obesity
研究组 & 干预措施
Control Group
This group will receive standard care plus lactation consultation only.
Supplement Group
This group will receive probiotic B. infantis supplementation, plus standard care and lactation consultation.
干预措施: Bifidobacterium (Dietary Supplement)
结局指标
主要结局
Infant fecal Bifidobacterium
时间窗: baseline, days 10, 14, 17, 21, 25, 29, 32, 40, 50, 60
Measure the change from baseline, during supplementation, and post supplementation
Incidence of Adverse Events and Treatments
时间窗: Months 4, 6, 8, 10, 12, 18 and 24
Gastrointestinal symptoms and related symptoms (diarrhea, vomiting, constipation, colic, irritability) after B. infantis supplementation will be determined and reported parental self-report questionnaire. General health status of the infant such as occurrence of any illness, health care visits for sickness, fever, antibiotic and medication use and parental assessments of infant's overall health.
Infant fecal B. infantis
时间窗: baseline, days 10, 14, 17, 21, 25, 29, 32, 40, 50, 60
Measure the change from baseline, during supplementation, and post supplementation
Infant fecal microbiota
时间窗: baseline, days 10, 14, 17, 21, 25, 29, 32, 40, 50, 60
Measure the change from baseline, during supplementation, and post supplementation
Infant fecal total bacteria
时间窗: baseline, days 10, 14, 17, 21, 25, 29, 32, 40, 50, 60
Measure the change from baseline, during supplementation, and post supplementation
Incidence of Adverse Events and Treatments
时间窗: Baseline-days 60
Gastrointestinal symptoms and related symptoms (discomfort passing bowel movements, vomiting, constipation, colic or irritability) before, during and after B. infantis supplementation will be determined and reported daily by parental self-report questionnaire. General health status of the infant such as occurrence of any illness, health care visits for sickness, fever, antibiotic and medication use and parental assessments of infant's overall health.
次要结局
- Fecal B. infantis-Follow-up(Months 4, 6, 8, 10, 12)
- Fecal Bifidobacterium-Follow-up(Months 4, 6, 8, 10, 12)
- Infant weight(birth, hospital discharge, days 15, 33, 61)
- Fecal inflammatory mediators(Baseline-days 60)
- Infant fecal bacteria oligosaccharide consumption(days 7, 14, 21, 32, 60)
- Fecal gut barrier function barrier markers(Baseline-days 60)
- Fecal short-chain fatty acids(Baseline-days 60)
- Infant fecal sialic acid concentrations(baseline, days 10, 14, 17, 21, 25, 29, 32, 40, 50, 60)
- Maternal fecal B. infantis, Bifidobacterium, total bacteria, and microbiota composition(baseline, day 60)
- Fecal lipopolysaccharide(Baseline-days 60)
- Fecal microbiome-Follow-up(Months 4, 6, 8, 10, 12)