NCT04934397终止不适用
Tolerance in Term Infants Fed a Partially Hydrolyzed Whey Protein-Based Formula With Oligosaccharides
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 18
- 试验地点
- 28
- 主要终点
- Fussiness
研究概览
简要总结
To assess the effects of partially hydrolyzed whey protein-based infant formula with oligosaccharides on symptoms of formula intolerance in healthy, term infants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 7 Days 至 65 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participant is judged to be in good health as determined from participant's medical history by parent report
- •Participant is a singleton from a full-term birth with a gestational age of 37-42 weeks
- •Participant's birth weight was >= 2490 g (~5 lbs. 8 oz.)
- •Participant is identified by parents as very fussy or extremely fussy on current formula in the Baseline Tolerance Evaluation
- •Participant is exclusively formula-fed at time of study entry and Parent(s) confirm their intention to feed their infant the study product as the sole source of nutrition for the duration of the study, unless instructed otherwise by their healthcare professional
- •Parent(s) of participants confirm their intention not to administer vitamin, mineral, human milk oligosaccharides (HMO), prebiotic(s), or probiotic(s) supplements (with the exception of vitamin D supplements if instructed by their healthcare professional), non-study formula, foods, juices, or other sources of nutrition to their infant from enrollment through the duration of the study
- •Participant's parent(s) has voluntarily signed and dated an Informed Consent Form (ICF), approved by an Institutional Review Board/Independent Ethics Committee (IRB/IEC) and provided Health Insurance Portability and Accountability Act (HIPAA) (or other applicable privacy regulation) authorization prior to any participation in the study
排除标准
- •An adverse maternal, fetal, or participant medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development. This includes but is not limited to suspected maternal substance abuse.
- •Participant is taking and plans to continue taking medications (including OTC, such as Mylicon® for gas), home remedies (such as juice for constipation), herbal preparations, or rehydration fluids that might affect GI tolerance.
- •Participant participates in another study that has not been approved as a concomitant study.
- •Participant has been fed a formula containing greater than two HMOs prior to study enrollment.
- •Participant has been fed an extensively hydrolyzed, amino acid based, or preterm formula within 14 days prior to enrollment and/or extensively hydrolyzed, amino acid based, or preterm formula has been recommended by the physician.
- •Participant has an allergy or intolerance to any ingredient in the study product
- •Participant has been treated with antibiotics within 7 days prior to enrollment
结局指标
主要结局
Fussiness
时间窗: Baseline to Study Day (SDAY) 2
Absolute and % change in fussiness severity reported from Daily Tolerance Diary
次要结局
- Gastrointestinal Tolerance(Baseline to SDAY 28)
- Stool(Baseline to SDAY 28)
研究者
研究点 (28)
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