To compare the frequency of regurgitation and other digestive outcomes between infants who receive an infant formula based on whole goat milk and an infant formula based on cow milk proteins during the transition period from breastfeeding to formula feeding, using predominantly breastfed infants as a reference group.
The study is a randomized, double-blind, parallel-group trial to study the effect of feeding infants goat milk or cow milk formula in the first 6 months of life on the prevalence of functional gastrointestinal disorders and other health outcomes, including gastrointestinal health and sleep during the transition from breastfeeding to formula-feeding. A predominantly breastfed group is used as a reference group.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
146
Infant formula based on whole goat milk, nutritionally suitable for infants aged 0-6 months
Infant formula based on cow milk proteins, nutritionally suitable for infants aged 0-6 months
Pediatric Nutrition Research Unit, Faculty of Medicine, Chulalongkorn University and King Chulalongkorn Memorial Hospital
Bangkok, Thailand
Change in daily frequency of regurgitation during the transition period from breastfeeding to formula feeding
Parental diary record of number of regurgitation per day reviewed at Day 0, Day 14 and Day 28
Time frame: From Day 0 to Day 28
Frequency of infant regurgitation
Rome IV criteria diagnosed by physician
Time frame: Day 0, Day 14, Day 28, and Age 8, 12, 16, 20 and 24 weeks
Frequency of infant colic
Rome IV criteria diagnosed by physician
Time frame: Day 0, Day 14, Day 28, and Age 8, 12, 16, 20 and 24 weeks
Frequency of functional constipation
Rome IV criteria diagnosed by physician
Time frame: Day 0, Day 14, Day 28, and Age 8, 12, 16, 20 and 24 weeks
Stool consistency
Stool consistency based on Brussels infants and toddler stool scale (BITSS)
Time frame: Day 0, Day 14, Day 28, and Age 8, 12, 16, 20 and 24 weeks
Stool frequency
Number of defecations per day
Time frame: Day 0, Day 14, Day 28, and Age 8, 12, 16, 20 and 24 weeks
Feeding difficulties
NeoEAT questionnaire
Time frame: Day 0, Day 14, Day 28, and Age 8, 16 and 24 weeks
Sleep
Brief Infant Sleep questionnaire
Time frame: Day 0, Day 28, and Age 12 and 24 weeks
Biochemical and metabolic markers: saliva markers
Saliva: inflammation markers (including enzymes reported in U/mL)
Time frame: Day 0 and Day 14
Biochemical and metabolic markers: saliva markers
Saliva: stress markers (including hormones reported in ng/mL)
Time frame: Day 0 and Day 14
Biochemical and metabolic markers: saliva markers
Saliva: inflammation markers (including proteins reported in µg/mL)
Time frame: Day 0 and Day 14
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.