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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Constipation - Functional; Infant Development; Gastrointestinal Disorder, Functional; Colic, Infantile; Regurgitation, Gastric
• Intervention / Treatment: Dietary supplement: Infant formula based on whole goat milk; Dietary supplement: infant formula based on cow milk proteins

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 Type: Interventional
• Enrollment (Actual): 141
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sophie Gallier, PhD; Phone Number: +64 7 848 9252; Email: sophie.gallier@dgc.co.nz

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 weeks to 4 months (Child)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Dairy Goat Co-operative (N.Z.) Limited
• Collaborators: Chulalongkorn University
• Investigators: Principal Investigator: Sirinuch Chomtho, MD, PhD, Chulalongkorn University

Study record dates

Study Major Dates

• Study Start (Actual): May 25, 2022
• Primary Completion (Estimated): March 28, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: April 21, 2022
• First Submitted That Met QC Criteria: May 3, 2022
• First Posted (Actual): May 6, 2022

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 9, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: regurgitation; infant formula; goat milk
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Signs and Symptoms, Digestive; Infant, Newborn, Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Laryngeal Diseases; Gastroesophageal Reflux; Gastrointestinal Diseases; Digestive System Diseases; Constipation; Colic; Laryngopharyngeal Reflux; Molecular Mechanisms of Pharmacological Action; Chelating Agents; Sequestering Agents; Caseins
• Other Study ID Numbers: DGC202106

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No