Effects of Goat Milk Formula on Gastrointestinal Comfort and Growth in Infants
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 5
SponsorRuijin Hospital
About this trial
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.
Eligibility criteria
Qualifiers
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)
Disqualifiers
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
Trial design
Treatments tested in this trial
- Goat Milk Formula
- Cow Milk Formula
Treatment groups
150 Participants
are divided into 3 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov