Colic, Infantile, Constipation - Functional, Gastrointestinal Disorder, Functional, Infant Development, Regurgitation, Gastric
Conditions
Keywords
infant formula, goat milk, regurgitation
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTInfant formula based on whole goat milk
Infant formula based on whole goat milk, nutritionally suitable for infants aged 0-6 months
DIETARY_SUPPLEMENTinfant formula based on cow milk proteins
Infant formula based on cow milk proteins, nutritionally suitable for infants aged 0-6 months
Sponsors
Chulalongkorn University
Dairy Goat Co-operative (N.Z.) Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Quadrupole
Intervention model description
Parallel assignment
Eligibility
Sex/Gender
ALL
Age
2 Weeks to 4 Months
Healthy volunteers
Yes
Inclusion criteria
* healthy full-term born infants (≥ 37 weeks + 0 days and \< 41 weeks + 6 days of gestation) * birth weight ≥ 2.5 kg and ≤ 4.5 kg * born from a singleton pregnancy * live in Bangkok or nearby with no plan for geographical migration before 6 months of age * for experimental and active comparator groups only: parent(s) has expressed the intention to partially (in combination with breastfeeding) or fully formula-feed the infant and ready to enroll in the study before the age of 4 months/120 days * for no intervention group only: parent(s) has expressed the intention to predominantly breastfeed (according to study definition) and ready to enroll in the study before the age of 4 months/120 days * infant has been predominantly breastfed for at least 2 weeks before enrollment * parent(s) has sufficient Thai language skills to understand the study information, the informed consent, and to comply with the study procedure * parent(s) is willing and deemed able to fulfil the requirements of the study protocol and procedures * at least one parent is of legal age of consent
Exclusion criteria
* infant has any disorder considered to interfere with nutrition, growth or development of the immune system * participation of the infant in any other interventional trial or participation of the mother in any intervention trial with infant follow-up * for experimental and active comparator groups only: infant has been formula-fed for more than 1 week before enrolment * for experimental and active comparator groups only: cow milk allergy or intolerance of the infant * for experimental and active comparator groups only: enrolled infant who never consumed any study product until the first visit 2 weeks following enrolment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in daily frequency of regurgitation during the transition period from breastfeeding to formula feeding | From Day 0 to Day 28 | Parental diary record of number of regurgitation per day reviewed at Day 0, Day 14 and Day 28 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of infant colic | Day 0, Day 14, Day 28, and Age 8, 12, 16, 20 and 24 weeks | Rome IV criteria diagnosed by physician |
| Frequency of functional constipation | Day 0, Day 14, Day 28, and Age 8, 12, 16, 20 and 24 weeks | Rome IV criteria diagnosed by physician |
| Stool consistency | Day 0, Day 14, Day 28, and Age 8, 12, 16, 20 and 24 weeks | Stool consistency based on Brussels infants and toddler stool scale (BITSS) |
| Frequency of infant regurgitation | Day 0, Day 14, Day 28, and Age 8, 12, 16, 20 and 24 weeks | Rome IV criteria diagnosed by physician |
| Feeding difficulties | Day 0, Day 14, Day 28, and Age 8, 16 and 24 weeks | NeoEAT questionnaire |
| Sleep | Day 0, Day 28, and Age 12 and 24 weeks | Brief Infant Sleep questionnaire |
| Biochemical and metabolic markers: saliva markers | Day 0 and Day 14 | Saliva: inflammation markers (including enzymes reported in U/mL) |
| Stool frequency | Day 0, Day 14, Day 28, and Age 8, 12, 16, 20 and 24 weeks | Number of defecations per day |
Countries
Thailand
Outcome results
None listed