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.

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