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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Gastrointestinal Disorder, Functional, Regurgitation, Gastric, Colic, Infantile, Constipation - Functional, Infant Development

Intervention / Treatment
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* Dietary Supplement: Infant formula based on whole goat milk
* Dietary Supplement: infant formula based on cow milk proteins


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Weeks
Maximum Age: 4 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: infant formula based on whole goat milk<br> | Dietary Supplement: Infant formula based on whole goat milk<br>* Infant formula based on whole goat milk, nutritionally suitable for infants aged 0-6 months<br>|
| Active Comparator: Infant formula based on cow milk proteins<br> | Dietary Supplement: infant formula based on cow milk proteins<br>* Infant formula based on cow milk proteins, nutritionally suitable for infants aged 0-6 months<br>|
| No Intervention: Predominantly breastmilk<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | From Day 0 to Day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of infant regurgitation | Rome IV criteria diagnosed by physician | 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 | 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 | 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) | Day 0, Day 14, Day 28, and Age 8, 12, 16, 20 and 24 weeks | 
| Stool frequency | Number of defecations per day | Day 0, Day 14, Day 28, and Age 8, 12, 16, 20 and 24 weeks | 
| Feeding difficulties | NeoEAT questionnaire | Day 0, Day 14, Day 28, and Age 8, 16 and 24 weeks | 
| Sleep | Brief Infant Sleep questionnaire | 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) | Day 0 and Day 14 | 
| Biochemical and metabolic markers: saliva markers | Saliva: stress markers (including hormones reported in ng/mL) | Day 0 and Day 14 | 
| Biochemical and metabolic markers: saliva markers | Saliva: inflammation markers (including proteins reported in µg/mL) | Day 0 and Day 14 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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infant formula, goat milk, regurgitation