Clinical trial NCT05363553: Transition to Infant Formula Feeding on Gastrointestinal Regurgitation (TIGER) Study
Official title: Transition to Infant Formula Feeding on Gastrointestinal Regurgitation (TIGER) Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastrointestinal Disorder, Functional
Regurgitation, Gastric
Colic, Infantile
Constipation - Functional
Infant Development
Keywords: infant formula
goat milk
regurgitation
Lead sponsor: Dairy Goat Co-operative (N.Z.) Limited
Sponsor class: INDUSTRY
Collaborators: name: Chulalongkorn University
First posted: 2022-05-06
Enrollment: 146
Sex: ALL
Minimum age (years): 2
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel assignment
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in daily frequency of regurgitation during the transition period from breastfeeding to formula feeding
timeFrame: From Day 0 to Day 28
Secondary outcomes:
measure: Frequency of infant regurgitation
timeFrame: Day 0, Day 14, Day 28, and Age 8, 12, 16, 20 and 24 weeks
measure: Frequency of infant colic
timeFrame: Day 0, Day 14, Day 28, and Age 8, 12, 16, 20 and 24 weeks
measure: Frequency of functional constipation
timeFrame: Day 0, Day 14, Day 28, and Age 8, 12, 16, 20 and 24 weeks
measure: Stool consistency
timeFrame: Day 0, Day 14, Day 28, and Age 8, 12, 16, 20 and 24 weeks
measure: Stool frequency
timeFrame: Day 0, Day 14, Day 28, and Age 8, 12, 16, 20 and 24 weeks
measure: Feeding difficulties
timeFrame: Day 0, Day 14, Day 28, and Age 8, 16 and 24 weeks
measure: Sleep
timeFrame: Day 0, Day 28, and Age 12 and 24 weeks
measure: Biochemical and metabolic markers: saliva markers
timeFrame: Day 0 and Day 14
measure: Biochemical and metabolic markers: saliva markers
timeFrame: Day 0 and Day 14
measure: Biochemical and metabolic markers: saliva markers
timeFrame: Day 0 and Day 14
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Pediatric Nutrition Research Unit, Faculty of Medicine, Chulalongkorn University and King Chulalongkorn Memorial Hospital
Study officials:
affiliation: Chulalongkorn University
name: Sirinuch Chomtho, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: