NCT05129384终止不适用
Colonization of the Infant Gut With B. Infantis EVC001 to Reduce Symptoms of Colic
Evolve BioSystems, Inc.2 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2022年2月23日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Change in crying/fussing duration
研究概览
简要总结
To investigate whether B. infantis EVC001 colonization in the infant gut can reduce symptoms of colic
详细描述
There is evidence to support that B. infantis EVC001 supplementation may ameliorate symptoms associated with colic by establishing and maintaining the necessary gut microbial composition to promote proper barrier and immune function in infants. The primary objective of this study is to assess the effect of the probiotic, B. infantis EVC001, on reducing the duration of crying/fussing symptoms of breastfed infants diagnosed with infantile colic from Baseline to Day 14.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
This is a double-blind, randomized, placebo-controlled study
入排标准
- 年龄范围
- 14 Days 至 42 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Infants with a diagnosis of infantile colic per Rome IV criteria and reported to cry/fuss for ≥ 3 hours/day, within a 24-hour period as determined by the 24-hour cry/fuss eDiary AND 24 hours of LENA vocalizations
- •Infants with a gestational period of ≥ 37 to 42 weeks
- •Infants between 14 and ≤ 42 days of life at the completion of screening/baseline tasks
- •Infants exclusively breastfed for at least 7 days immediately prior to enrollment and with mother's intent to continue feeding breast milk exclusively for the duration of the study
- •Mothers willing to use their own electronic device(s) to download and utilize all required study software (decentralized trial platform on a mobile device and the LENA device software on a Windows 10 or higher laptop or desktop that has at least 10 GB of free space and fast, reliable internet)
- •Mother is fluent in English
排除标准
- •Infants born in multiple birth (i.e., twins, triplets, etc.)
- •Infants born with medical complications (i.e., neurological, cerebral palsy, confirmed food allergies)
- •Infants with current evidence of failure to thrive, fever, or illness
- •Infants with any GI tract abnormalities
- •Antibiotic, infant formula, solid food or iron supplement intake within 7 days prior to enrollment or mother's intent to feed non-study probiotics, prebiotics, infant formula, solid food or iron supplements to their infant at any time during the study
- •Infants who have consumed any probiotics since birth
- •Unwillingness to discontinue/avoid products used to treat IC (i.e., Simethicone, gripe water, colic drops, etc.) during the study. Note: consumption of IC products prior to the baseline period is NOT exclusionary
- •Maternal use of probiotics containing B. infantis during pregnancy, after the baby's birth and/or intent to use probiotics containing B. infantis at any time throughout the study
- •Maternal smoking or smoking within the home by any household member currently or during pregnancy
- •Mother following exclusionary diet due to her infant's colic (i.e., dairy elimination diet)
- •Any infant the Investigator deems to be ineligible for participation
结局指标
主要结局
Change in crying/fussing duration
时间窗: Baseline to Day 14
Assess the effect of the probiotic, B. infantis EVC001, on duration of crying/fussing symptoms of breastfed infants diagnosed with infantile colic
次要结局
未报告次要终点
研究者
研究点 (2)
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