Transition to Infant Formula Feeding on Gastrointestinal... | NCT05363553

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

NCT05363553

Sponsor

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

Status

Completed

Last Update Posted

Sep 19, 2024Actual

Enrollment

146Actual

Phase

Not Applicable

Conditions

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

Interventions

Infant formula based on whole goat milk
infant formula based on cow milk proteins

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Sep 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 25, 2022Actual

Primary Completion Date

Apr 30, 2024Actual

Completion Date

Aug 28, 2024Actual

First Submitted Date

Apr 21, 2022

First Submission Date that Met QC Criteria

May 3, 2022

First Posted Date

May 6, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 8, 2024

Last Update Posted Date

Sep 19, 2024Actual

Name	Class
Chulalongkorn University	OTHER

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

146Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
infant formula based on whole goat milk	Experimental	Dietary Supplement: Infant formula based on whole goat milk
Infant formula based on cow milk proteins	Active Comparator	Dietary Supplement: infant formula based on cow milk proteins
Predominantly breastmilk	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Infant formula based on whole goat milk	Dietary Supplement	Infant formula based on whole goat milk, nutritionally suitable for infants aged 0-6 months	infant formula based on whole goat milk

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Weeks

Maximum Age

4 Months

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D005767	Gastrointestinal Diseases
D057045	Laryngopharyngeal Reflux
D003085	Colic
D005764	Gastroesophageal Reflux

ID	Term
D004066	Digestive System Diseases
D015154	Esophageal Motility Disorders
D003680	Deglutition Disorders
D004935	Esophageal Diseases
D007818	Laryngeal Diseases
D012140	Respiratory Tract Diseases
D007232	Infant, Newborn, Diseases
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities