The FOUNDATION Study: Hospital Formulation Of B. Infantis EVC001 Utilized In The NICU To Demonstrate Tolerability In The Investigator's Preterm Neonates
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Tolerability: Frequency of Probiotic Sepsis, as determined by the Principal Investigator
研究概览
简要总结
The FOUNDATION study will evaluate the tolerability of feeding preterm infants a B. infantis probiotic (EVC001) as the primary endpoint. This particular strain of Bifidobacterium has been shown to uniquely utilize oligosaccharides found in human breast milk, possibly providing a nutritional benefit for the infant consuming breast milk when B. infantis is colonized in the gut.
详细描述
This is a single-center, open-label, prospective, cohort study of an infant probiotic (Food for Special Dietary Use) conducted in the neonatal intensive care unit (NICU). Each subject enrolled will be in the study from the time of consent (within 10 days of birth) to hospital discharge. A prospective control cohort of 15 infants will initially be enrolled. Fifteen (15) infants will then be enrolled into the B. infantis cohort. Infants in the B. infantis cohort will receive a daily feeding of B. infantis EVC001 in MCT oil until hospital discharge.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- — 至 10 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Birth weight < 1500 grams or gestational age at birth < 33 and 0/7 weeks
- •≤ 10 days of life and considered viable
- •Consuming exclusive human milk diet (mother's milk or donor milk) with or without fortifier at time of enrollment
- •Toleration of 1.0 mL bolus enteral feeds
排除标准
- •Presence of septicemia or active infection as determined by positive 48-hour blood cultures
- •Necrotizing enterocolitis
- •Pulmonary hypoplasia
- •Presence of clinically significant congenital heart disease or other major congenital malformation
- •Any infant the Investigator deems to be ineligible for participation
结局指标
主要结局
Tolerability: Frequency of Probiotic Sepsis, as determined by the Principal Investigator
时间窗: From the time of study product administration through study completion, which occurs at the time of hospital discharge. Anticipated length of stay for this patient population is up to 84 days.
Tolerability of B. infantis EVC001 in preterm infants as determined by Probiotic Sepsis, as diagnosed by the PI. Frequency of Probiotic Sepsis will be provided by treatment group.
Tolerability: Frequency of Blood in Stool
时间窗: From the time of study product administration through study completion, which occurs at the time of hospital discharge. Anticipated length of stay for this patient population is up to 84 days.
Tolerability of B. infantis EVC001 in preterm infants as determined by visualized frank blood in stool. Frequency of blood in stool will be provided by treatment group.
Tolerability: Frequency of disruption in skin integrity in diaper area
时间窗: From the time of study product administration through study completion, which occurs at the time of hospital discharge. Anticipated length of stay for this patient population is up to 84 days.
Tolerability of B. infantis EVC001 in preterm infants as determined by disruption in skin integrity in diaper area requiring treatment. Frequency of disruption in skin integrity will be provided by treatment group.
Tolerability: Frequency of Abdominal Distension
时间窗: From the time of study product administration through study completion, which occurs at the time of hospital discharge. Anticipated length of stay for this patient population is up to 84 days.
Tolerability of B. infantis EVC001 in preterm infants as determined by abdominal distension causing treatment, diagnostics, or change in institutional standard of care. Frequency of abdominal distension will be provided by treatment group.
Tolerability: Frequency of Adverse Events
时间窗: From the time of study product administration through study completion, which occurs at the time of hospital discharge. Anticipated length of stay for this patient population is up to 84 days.
Tolerability of B. infantis EVC001 in preterm infants as determined by Adverse Events. Frequency of treatment-emergent adverse events (TEAEs), serious TEAEs and TEAEs causing premature discontinuation will be provided by treatment group.
Tolerability: Frequency of Emesis
时间窗: From the time of study product administration through study completion, which occurs at the time of hospital discharge. Anticipated length of stay for this patient population is up to 84 days.
Tolerability of B. infantis EVC001 in preterm infants as determined by significant or bilious emesis causing treatment, diagnostics, or change in institutional standard of care. Frequency of emesis will be provided by treatment group.
次要结局
- Changes in the preterm gut microbiome over time related to probiotic supplementation(Baseline; Study Days 14 and 28; and 34, 36, and 38 weeks gestational age)
- B. infantis levels in preterm infant stool related to probiotic supplementation(Baseline; Study Days 14 and 28; and 34, 36, and 38 weeks gestational age)
- Bifidobacterium levels in preterm infant stool related to probiotic supplementation(Baseline; Study Days 14 and 28; and 34, 36, and 38 weeks gestational age)