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

Primary Purpose

Gastrointestinal Disorder, Functional, Regurgitation, Gastric, Colic, Infantile

Status

Recruiting

Phase

Not Applicable

Locations

Thailand

Study Type

Interventional

Intervention

Infant formula based on whole goat milk

infant formula based on cow milk proteins

About this trial

This is an interventional prevention trial for Gastrointestinal Disorder, Functional focused on measuring infant formula, goat milk, regurgitation

Eligibility Criteria

2 Weeks - 4 Months (Child)All SexesAccepts 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

Sites / Locations

Pediatric Nutrition Research Unit, Faculty of Medicine, Chulalongkorn University and King Chulalongkorn Memorial HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

infant formula based on whole goat milk

Infant formula based on cow milk proteins

Predominantly breastmilk

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Frequency of infant regurgitation

Rome IV criteria diagnosed by physician

Frequency of infant colic

Rome IV criteria diagnosed by physician

Frequency of functional constipation

Rome IV criteria diagnosed by physician

Stool consistency

Stool consistency based on Brussels infants and toddler stool scale (BITSS)

Stool frequency

Number of defecations per day

Feeding difficulties

NeoEAT questionnaire

Sleep

Brief Infant Sleep questionnaire

Biochemical and metabolic markers: saliva markers

Saliva: inflammation markers (including enzymes reported in U/mL)

Biochemical and metabolic markers: saliva markers

Saliva: stress markers (including hormones reported in ng/mL)

Biochemical and metabolic markers: saliva markers

Saliva: inflammation markers (including proteins reported in µg/mL)

Full Information

NCT ID

NCT05363553

First Posted

April 21, 2022

Last Updated

July 1, 2023

Sponsor

Dairy Goat Co-operative (N.Z.) Limited

Collaborators

Chulalongkorn University

1. Study Identification

Unique Protocol Identification Number

NCT05363553

Brief Title

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

Acronym

TIGER

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

May 25, 2022 (Actual)

Primary Completion Date

July 2024 (Anticipated)

Study Completion Date

January 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Dairy Goat Co-operative (N.Z.) Limited

Collaborators

Chulalongkorn University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

infant formula, goat milk, regurgitation

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Parallel assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

Quadrupole

Allocation

Randomized

Enrollment

160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

infant formula based on whole goat milk

Arm Type

Experimental

Arm Title

Infant formula based on cow milk proteins

Arm Type

Active Comparator

Arm Title

Predominantly breastmilk

Arm Type

No Intervention

Intervention Type

Dietary Supplement

Intervention Name(s)

Infant formula based on whole goat milk

Intervention Description

Infant formula based on whole goat milk, nutritionally suitable for infants aged 0-6 months

Intervention Type

Dietary Supplement

Intervention Name(s)

infant formula based on cow milk proteins

Intervention Description

Infant formula based on cow milk proteins, nutritionally suitable for infants aged 0-6 months

Primary Outcome Measure Information:

Title

Change in daily frequency of regurgitation during the transition period from breastfeeding to formula feeding

Description

Parental diary record of number of regurgitation per day reviewed at Day 0, Day 14 and Day 28

Time Frame

From Day 0 to Day 28

Secondary Outcome Measure Information:

Title

Frequency of infant regurgitation

Description

Rome IV criteria diagnosed by physician

Time Frame

Day 0, Day 14, Day 28, and Age 8, 12, 16, 20 and 24 weeks

Title

Frequency of infant colic

Description

Rome IV criteria diagnosed by physician

Time Frame

Day 0, Day 14, Day 28, and Age 8, 12, 16, 20 and 24 weeks

Title

Frequency of functional constipation

Description

Rome IV criteria diagnosed by physician

Time Frame

Day 0, Day 14, Day 28, and Age 8, 12, 16, 20 and 24 weeks

Title

Stool consistency

Description

Stool consistency based on Brussels infants and toddler stool scale (BITSS)

Time Frame

Day 0, Day 14, Day 28, and Age 8, 12, 16, 20 and 24 weeks

Title

Stool frequency

Description

Number of defecations per day

Time Frame

Day 0, Day 14, Day 28, and Age 8, 12, 16, 20 and 24 weeks

Title

Feeding difficulties

Description

NeoEAT questionnaire

Time Frame

Day 0, Day 14, Day 28, and Age 8, 16 and 24 weeks

Title

Sleep

Description

Brief Infant Sleep questionnaire

Time Frame

Day 0, Day 28, and Age 12 and 24 weeks

Title

Biochemical and metabolic markers: saliva markers

Description

Saliva: inflammation markers (including enzymes reported in U/mL)

Time Frame

Day 0 and Day 14

Title

Biochemical and metabolic markers: saliva markers

Description

Saliva: stress markers (including hormones reported in ng/mL)

Time Frame

Day 0 and Day 14

Title

Biochemical and metabolic markers: saliva markers

Description

Saliva: inflammation markers (including proteins reported in µg/mL)

Time Frame

Day 0 and Day 14

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Weeks

Maximum Age & Unit of Time

4 Months

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Sophie Gallier, PhD

Phone

+64 7 848 9252

sophie.gallier@dgc.co.nz

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sirinuch Chomtho, MD, PhD

Organizational Affiliation

Chulalongkorn University

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Bangkok

Country

Thailand

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sirinuch Chomtho, MD, PhD

schomtho@gmail.com

First Name & Middle Initial & Last Name & Degree

Orapa Suteerojntrakool, MD

orapa.s@chula.ac.th

First Name & Middle Initial & Last Name & Degree

Sirinuch Chomtho, MD, PhD

First Name & Middle Initial & Last Name & Degree

Sungkom Jongpipatvanich, MD

First Name & Middle Initial & Last Name & Degree

Orapa Suteerojntrakool, MD

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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

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