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

Not Applicable

Active, not recruiting

• Conditions: Colic, Infantile; Constipation - Functional; Infant Development; Gastrointestinal Disorder, Functional; Regurgitation, Gastric
• Interventions: Dietary Supplement: infant formula based on cow milk proteins; Dietary Supplement: Infant formula based on whole goat milk

• Registration Number: NCT05363553
• Lead Sponsor: Dairy Goat Co-operative (N.Z.) Limited

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.

Study Timeline

• Study First Submitted: 2022-04-21
• Study First Submitted QC: 2022-05-03
• Study First Posted: 2022-05-06
• Study Start: 2022-05-25
• Primary Completion: 2024-03-31
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-13
• Last Update Posted: 2024-05-16
• Study Completion: 2024-08-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 146

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Infant formula based on cow milk proteins	infant formula based on cow milk proteins	-
infant formula based on whole goat milk	Infant formula based on whole goat milk	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Stool frequency	Day 0, Day 14, Day 28, and Age 8, 12, 16, 20 and 24 weeks	Number of defecations per day
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
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
Sleep	Day 0, Day 28, and Age 12 and 24 weeks	Brief Infant Sleep questionnaire
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
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)
Feeding difficulties	Day 0, Day 14, Day 28, and Age 8, 16 and 24 weeks	NeoEAT questionnaire
Biochemical and metabolic markers: saliva markers	Day 0 and Day 14	Saliva: inflammation markers (including proteins reported in µg/mL)

Trial Locations

Locations (1)

Pediatric Nutrition Research Unit, Faculty of Medicine, Chulalongkorn University and King Chulalongkorn Memorial Hospital; 🇹🇭 Bangkok, Thailand