NCT03387124已完成不适用
Characterization of Stool Consistency and Fecal Microbiota of Breastfed Infants
Société des Produits Nestlé (SPN)1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2018年1月22日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Stool Consistency Score
研究概览
简要总结
The purpose of this study is to evaluate the stool consistency and microbiota composition of healthy breastfed infants.
详细描述
This is a prospective, observational, non-interventional study. The purpose of this study is to evaluate the stool consistency and variability in fecal microbiota composition, diversity, and abundance of defined taxa in 75 healthy, term, exclusively breastfed infants. All enrolled infants will participate in the trial for approximately 169 days.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Days 至 26 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Written informed consent
- •Infants whose parent(s)/LAR who have reached the legal age of majority in the Philippines
- •Infants whose parent(s)/LAR are willing and able to comply with study requirements
- •Infants whose parent(s)/LAR who are able to be contacted directly by telephone throughout the study
- •Healthy term, singleton infant at birth
- •Between 21 to 26 days post-natal age at enrollment visit
- •Weight-for-length and head circumference-for-age z-scores are ≥ -3 and ≤ +3 according to WHO Child Growth Standards
- •Infants of parent(s)/LAR who have previously made the decision to breastfeed their infant at the time of enrollment
排除标准
- •Infants with conditions requiring infant feedings other than those specified in the protocol
- •Infants receiving weaning foods or liquids
- •Infants who have a medical condition or history that could increase the risk associated with study participation or interfere with the interpretation of study results
- •Infants who are presently receiving or have received medications that could interfere with the interpretation of study results
- •Infants or infants whose parent(s)/LAR who cannot be expected to comply with the protocol or with study procedures
结局指标
主要结局
Stool Consistency Score
时间窗: 155 days
次要结局
- Fecal Microbiota Composition(155 days)
- Changes in Head Circumference from baseline to 155 days(155 days)
- Changes in Length from baseline to 155 days(155 days)
- Changes in Weight from baseline to 155 days(155 days)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Gastrointestinal Tolerance And General Health Status Of Healthy Term Infants Fed A New Infant FormulaHealthyNCT01370967Société des Produits Nestlé (SPN)460
撤回
不适用
Comparison of Microbiome Composition and Biomarkers in Pharmaco Resistant and Pharmaco-Sensitive EpilepsyEpilepsy in ChildrenPharmaco-Resistant EpilepsyNCT04308252Senda Biosciences
已完成
不适用
Study on analysis of gut bacteria and their by products from stool samplesCTRI/2022/02/040469For BugWorks Research India Pvt Ltd Leucine Rich Bio Pvt Ltd
已完成
1 期
Effect of a Lacidofil® STRONG in Healthy Adults Taking Antibiotic TreatmentAntibiotic Associated DiarrheaNCT01941160KGK Science Inc.160
已完成
不适用
Pilot Study of Gut Commensals in Antiphospholipid SyndromeAntiphospholipid Syndrome (APS)NCT01787305Yale University16