NCT06312059

Goat or Cow Milk Based Infant Formula GMS

Growth Tolerance and Safety Study of Healthy Term Infants Consuming a Goat or Cow Milk Based Infant Formula

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 409 (actual)
• Sponsor: Kendal Nutricare Ltd · Industry
• Sex: All
• Age: 14 Days
• Healthy volunteers: Accepted

Summary

This study is a non-inferiority, decentralized, randomized, double-blind, controlled clinical trial evaluating the growth, tolerance, and safety of a goat's-milk test infant formula (Test Formula 1; TF1) and a cow's-milk test infant formula (Test Formula 2; TF2), each compared to a cow's-milk infant formula commercially available in the United States (Control Formula; CF).

Conditions

• Growth

Interventions

Type	Name	Description
OTHER	Advance Infant Formula Powder	Sole source infant nutrition for the control arm.
OTHER	"Kendamil Cow milk test product	Sole source infant nutrition for the cow milk test arm.
OTHER	"Kendamil goat milk test product	Sole source infant nutrition for the goat milk test arm.

Timeline

• Start date: 2023-12-14
• Primary completion: 2024-08-15
• Completion: 2024-08-15
• First posted: 2024-03-15
• Last updated: 2026-03-24

Locations

1 site across 1 country: United States