NCT05783037

Growth, Tolerance, and Safety Study of Healthy Term Infants Consuming a New Organic Cow's Milk-Based Infant Formula

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 394 (actual)
• Sponsor: Bobbie Baby, Inc · Industry
• Sex: All
• Age: 0 Days – 11 Days
• Healthy volunteers: Accepted

Summary

The goal of this study is to demonstrate that healthy term babies who are fed Bobbie's study formula grow at the same rate as those fed with an existing cow's milk formula. Breastfeeding is the ultimate reference for infant nutrition. Therefore, this study also includes a group of breastfed babies for additional comparison.

Detailed description

This is a 16 week, double-blind, randomized, controlled trial designed to demonstrate that a new infant formula for term infants supports age-appropriate growth. The study has been designed in accordance with Good Clinical Practice guidelines and the requirements of the Code of Federal Regulations 21 CFR 106.96

Conditions

• Healthy Growth

Interventions

Type	Name	Description
OTHER	New Organic Infant Formula	New organic infant formula fed daily ad libitum
OTHER	Commercial Organic Infant Formula	Commercially available organic infant formula fed daily ad libitum

Timeline

• Start date: 2023-03-29
• Primary completion: 2025-12-04
• Completion: 2025-12-07
• First posted: 2023-03-24
• Last updated: 2026-02-05

Locations

1 site across 1 country: United States