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.
연구 개요
상태
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Xinqiong Wang
- 전화번호: 021-64370045
- 이메일: wangxq1983@126.com
참여기준
자격 기준
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설명
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
공부 계획
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디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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.
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Infants will receive goat milk-based formula as their primary feeding during the intervention period, according to standard feeding practices.
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활성 비교기: 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.
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Infants will receive standard cow milk-based formula as their primary feeding during the intervention period, according to routine feeding practices.
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간섭 없음: Healthy breastfeeding
No feeding intervention will be performed; only fecal samples and clinical data will be collected.
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주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Overall Response Rate Based on Infant Composite Comfort Score (ICCS) at Day 14
기간: Baseline to Day 14
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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%.
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Baseline to Day 14
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in Gastrointestinal Symptom Burden Score
기간: Baseline to Day 28
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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).
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Baseline to Day 28
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Resolution Rate of Individual Gastrointestinal Symptoms
기간: Day 28
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Proportion of infants with complete resolution of individual gastrointestinal symptoms (e.g., abdominal distension, crying, vomiting) by Day 28.
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Day 28
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Change in Daily Sleep Duration
기간: Baseline to Day 28
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Change in total daily sleep duration (minutes) based on caregiver-recorded 24-hour infant behavior diary.
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Baseline to Day 28
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Change in Daily Awake and Content Time
기간: Baseline to Day 28
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Change in total daily duration of awake and content state as reported by caregivers.
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Baseline to Day 28
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Change in Parent-Reported Infant Comfort/Feeding Experience
기간: Baseline to Day 28
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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
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Change in Parent-Reported Infant Feeding Experience
기간: Baseline to Day 28
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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
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Change in Weight-for-Age Z-Score
기간: Baseline to Day 28
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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.
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Baseline to Day 28
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Change in Head Circumference-for-Age Z-Score
기간: Baseline to Day 28
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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.
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Baseline to Day 28
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Change in Length-for-Age Z-Score
기간: Baseline to Day 28
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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.
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Baseline to Day 28
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Changes in Gut Microbiota Composition
기간: Baseline and Week 4
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Changes in gut microbiota composition, including relative abundance of key bacterial taxa, assessed by 16S rRNA sequencing of stool samples.
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Baseline and Week 4
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Change in Fecal Calprotectin Levels
기간: Baseline and Week 4
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Change in fecal calprotectin concentration as a marker of intestinal inflammation.
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Baseline and Week 4
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