NCT05363553

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 146 (actual)
• Sponsor: Dairy Goat Co-operative (N.Z.) Limited · Industry
• Sex: All
• Age: 2 Weeks – 4 Months
• Healthy volunteers: Accepted

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.

Conditions

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

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Infant formula based on whole goat milk	Infant formula based on whole goat milk, nutritionally suitable for infants aged 0-6 months
DIETARY_SUPPLEMENT	infant formula based on cow milk proteins	Infant formula based on cow milk proteins, nutritionally suitable for infants aged 0-6 months

Timeline

• Start date: 2022-05-25
• Primary completion: 2024-04-30
• Completion: 2024-08-28
• First posted: 2022-05-06
• Last updated: 2024-09-19

Locations

1 site across 1 country: Thailand