Effects of Goat Milk Formula on Gastrointestinal Comfort and Growth in Infants
A Multicenter, Randomized, Controlled Trial to Evaluate the Effects of Goat Milk Formula on Gastrointestinal Comfort, Behavioral Status, and Early Growth and Development in Infants
Infant gastrointestinal discomfort is common in early life and can affect feeding, sleep, and overall well-being. Goat milk formula, due to its unique protein composition and smaller fat globules, may be easier to digest and potentially improve gastrointestinal tolerance in infants.
This study is a multicenter, randomized, controlled trial designed to evaluate the effects of goat milk formula compared with standard cow milk formula in infants aged 0-5 months with gastrointestinal discomfort. The study will assess improvements in gastrointestinal symptoms, overall comfort, behavioral status, and early growth and development, as well as explore potential changes in gut microbiota and intestinal inflammation.
研究概览
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Xinqiong Wang
- 电话号码：021-64370045
- 邮箱：wangxq1983@126.com
参与标准
资格标准
适合学习的年龄
- 孩子
接受健康志愿者
描述
Inclusion Criteria:
- Infants aged 0 to 5 months at enrollment
- Full-term birth (gestational age ≥37 weeks)
- Birth weight ≥2500 g
- Infants with symptoms of gastrointestinal discomfort (e.g., abdominal distension, excessive crying, regurgitation, or feeding intolerance)
- Parents or legal guardians able and willing to provide written informed consent and comply with study procedures
Exclusion Criteria:
- Infants with known or suspected organic gastrointestinal diseases (e.g., congenital malformations, Hirschsprung disease)
- History of severe perinatal complications or significant systemic diseases
- Known or suspected cow's milk protein allergy or other food allergies
- Use of antibiotics, probiotics, or other medications that may affect gastrointestinal function within 2 weeks prior to enrollment
- Participation in another clinical study within the past 3 months
- Any condition that, in the investigator's judgment, may interfere with study participation or outcome assessment For the reference cohort: healthy breastfed infants without significant gastrointestinal symptoms
学习计划
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Goat Milk Formula Group
Infants in this group will be fed with goat milk-based infant formula and receive feeding and care guidance during the study period.
|
Infants will receive goat milk-based formula as their primary feeding during the intervention period, according to standard feeding practices.
|
|
有源比较器：Cow Milk Formula Group
Infants in this group will continue to receive standard cow milk-based infant formula and receive feeding and care guidance during the study period.
|
Infants will receive standard cow milk-based formula as their primary feeding during the intervention period, according to routine feeding practices.
|
|
无干预：Healthy breastfeeding
No feeding intervention will be performed; only fecal samples and clinical data will be collected.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Overall Response Rate Based on Infant Composite Comfort Score (ICCS) at Day 14
大体时间：Baseline to Day 14
|
The overall response rate is defined as the proportion of participants in each group showing a ≥30% improvement in ICCS from baseline to Day 14. ICCS is a composite measure combining gastrointestinal symptom burden and behavioral state, with total scores ranging from 0 to 30.
Higher scores indicate better overall comfort (better outcome).
Response is categorized as: Markedly Effective (improvement ≥50%), Effective (improvement ≥30% to <50%), and Ineffective (improvement <30% or worsening).
The overall response rate is calculated as (Markedly Effective + Effective) / Total Cases × 100%.
|
Baseline to Day 14
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in Gastrointestinal Symptom Burden Score
大体时间：Baseline to Day 28
|
Change in gastrointestinal symptom burden score from baseline to Day 28, assessed using the Infant Gastrointestinal Symptom Assessment Scale.
The scale ranges from 0 to 15, with higher scores indicating greater symptom burden (worse outcome).
|
Baseline to Day 28
|
|
Resolution Rate of Individual Gastrointestinal Symptoms
大体时间：Day 28
|
Proportion of infants with complete resolution of individual gastrointestinal symptoms (e.g., abdominal distension, crying, vomiting) by Day 28.
|
Day 28
|
|
Change in Daily Sleep Duration
大体时间：Baseline to Day 28
|
Change in total daily sleep duration (minutes) based on caregiver-recorded 24-hour infant behavior diary.
|
Baseline to Day 28
|
|
Change in Daily Awake and Content Time
大体时间：Baseline to Day 28
|
Change in total daily duration of awake and content state as reported by caregivers.
|
Baseline to Day 28
|
|
Change in Parent-Reported Infant Comfort/Feeding Experience
大体时间：Baseline to Day 28
|
Change from baseline to Day 28 in parent-reported infant comfort experience, assessed using the following instrument: Parenting Feeding and Nurturing Experience Questionnaire total score. This questionnaire consists of 5 items, each scored from 1 to 5, giving a total score range of 5 to 25. Higher scores indicate a more positive parenting and feeding experience (better outcome). |
Baseline to Day 28
|
|
Change in Parent-Reported Infant Feeding Experience
大体时间：Baseline to Day 28
|
Change from baseline to Day 28 in parent-reported infant feeding experience, assessed using the following instrument: Visual Analogue Scale (VAS) scores for parent-perceived infant overall comfort, feeding smoothness, and maternal anxiety. Each VAS item ranges from 0 to 10. For all three items, higher scores indicate better outcomes (i.e., more comfort, smoother feeding, and less anxiety). |
Baseline to Day 28
|
|
Change in Weight-for-Age Z-Score
大体时间：Baseline to Day 28
|
Change in weight-for-age Z-score from baseline to Day 28.
Weight is measured in kilograms (kg) using a calibrated electronic infant scale.
The Z-score is a continuous variable (standard deviation units relative to the WHO child growth standard), with a typical clinical range of -3 to +3.
Higher Z-scores indicate greater weight for age, generally reflecting better growth outcomes in this population.
|
Baseline to Day 28
|
|
Change in Head Circumference-for-Age Z-Score
大体时间：Baseline to Day 28
|
Change in head circumference-for-age Z-score from baseline to Day 28.
Head circumference is measured in centimeters (cm) using a non-stretchable measuring tape.
The Z-score is a continuous variable (standard deviation units relative to the WHO child growth standard), with a typical clinical range of -3 to +3.
Higher Z-scores indicate greater head circumference for age, reflecting appropriate brain and cranial growth.
|
Baseline to Day 28
|
|
Change in Length-for-Age Z-Score
大体时间：Baseline to Day 28
|
Change in length-for-age Z-score from baseline to Day 28.
Length is measured in centimeters (cm) using a standard infant length measurement board.
The Z-score is a continuous variable (standard deviation units relative to the WHO child growth standard), with a typical clinical range of -3 to +3.
Higher Z-scores indicate greater length for age, generally reflecting better growth outcomes in this population.
|
Baseline to Day 28
|
|
Changes in Gut Microbiota Composition
大体时间：Baseline and Week 4
|
Changes in gut microbiota composition, including relative abundance of key bacterial taxa, assessed by 16S rRNA sequencing of stool samples.
|
Baseline and Week 4
|
|
Change in Fecal Calprotectin Levels
大体时间：Baseline and Week 4
|
Change in fecal calprotectin concentration as a marker of intestinal inflammation.
|
Baseline and Week 4
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.