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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
150
Infants will receive goat milk-based formula as their primary feeding during the intervention period, according to standard feeding practices.
Infants will receive standard cow milk-based formula as their primary feeding during the intervention period, according to routine feeding practices.
Overall Response Rate Based on Infant Composite Comfort Score (ICCS) at 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%.
Time frame: Baseline to Day 14
Change in Gastrointestinal Symptom Burden Score
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).
Time frame: Baseline to Day 28
Resolution Rate of Individual Gastrointestinal Symptoms
Proportion of infants with complete resolution of individual gastrointestinal symptoms (e.g., abdominal distension, crying, vomiting) by Day 28.
Time frame: Day 28
Change in Daily Sleep Duration
Change in total daily sleep duration (minutes) based on caregiver-recorded 24-hour infant behavior diary.
Time frame: Baseline to Day 28
Change in Daily Awake and Content Time
Change in total daily duration of awake and content state as reported by caregivers.
Time frame: Baseline to Day 28
Change in Parent-Reported Infant Comfort/Feeding Experience
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).
Time frame: Baseline to Day 28
Change in Parent-Reported Infant Feeding Experience
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).
Time frame: Baseline to Day 28
Change in Weight-for-Age Z-Score
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.
Time frame: Baseline to Day 28
Change in Head Circumference-for-Age Z-Score
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.
Time frame: Baseline to Day 28
Change in Length-for-Age Z-Score
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.
Time frame: Baseline to Day 28
Changes in Gut Microbiota Composition
Changes in gut microbiota composition, including relative abundance of key bacterial taxa, assessed by 16S rRNA sequencing of stool samples.
Time frame: Baseline and Week 4
Change in Fecal Calprotectin Levels
Change in fecal calprotectin concentration as a marker of intestinal inflammation.
Time frame: Baseline and Week 4
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