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

Status: Completed
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 14 days
Maximum Age: 4 months
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
Thailand
Pediatric Nutrition Research Unit, Faculty of Medicine, Chulalongkorn University and King Chulalongkorn Memorial Hospital
Bangkok
Time Frame
Start Date: 2022-05-25
Completion Date: 2024-08-28
Participants
Target number of participants: 146
Treatments
Experimental: infant formula based on whole goat milk
Active_comparator: Infant formula based on cow milk proteins
No_intervention: Predominantly breastmilk
Authors
Sungkom Jongpipatvanich, Sirinuch Chomtho, Orapa Suteerojntrakool
Sponsors
Leads: Dairy Goat Co-operative (N.Z.) Limited
Collaborators: Chulalongkorn University

This content was sourced from clinicaltrials.gov