Transition to Infant Formula Feeding on Gastrointestinal Regurgitation (TIGER) Study

Dairy Goat Co-operative

Status

Completed

Conditions

Colic, Infantile

Constipation - Functional

Gastrointestinal Disorder, Functional

Regurgitation, Gastric

Infant Development

Treatments

Dietary Supplement: Infant formula based on whole goat milk

Dietary Supplement: infant formula based on cow milk proteins

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT05363553

DGC202106

Details and patient eligibility

About

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.

Full 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.

Enrollment

146 patients

Sex

All

Ages

2 weeks to 4 months old

Volunteers

Accepts Healthy Volunteers

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