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

NCT05363553 | Completed

• 1 other identifier: DGC202106
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

infant formula; goat milk; regurgitation

Outcome Measures

Primary Outcomes (1)

• 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 (10)

• Frequency of infant regurgitation

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

• Frequency of infant colic

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

• Frequency of functional constipation

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

• Stool consistency

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

• Stool frequency

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

Study Arms (3)

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

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

infant formula based on cow milk proteins DIETARY_SUPPLEMENT

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

Infant formula based on cow milk proteins

Eligibility Criteria

• Age: 2 Weeks - 4 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dairy Goat Co-operative (N.Z.) Limited: lead
• Chulalongkorn University: collaborator

Study Sites (1)

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

Bangkok, Thailand

Location

MeSH Terms

Conditions

Gastrointestinal Diseases; Laryngopharyngeal Reflux; Colic; Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Digestive System Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Laryngeal Diseases; Respiratory Tract Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Sirinuch Chomtho, MD, PhD

  Chulalongkorn University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Quadrupole
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel assignment

Study Record Dates

• First Submitted: April 21, 2022
• First Posted: May 6, 2022
• Study Start: May 25, 2022
• Primary Completion: April 30, 2024
• Study Completion: August 28, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

TH (1)