NCT06053112

The Trial of a New Infant Formula in Healthy Term Chinese Infants

Safety and Efficacy of Infant Formula Containing a Specific Blend of Six Human Milk Oligosaccharides: A Double-blind, Randomized, Controlled Trial

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 326 (actual)
• Sponsor: Junlebao Dairy Group Co., Ltd. · Industry
• Sex: All
• Age: 14 Days
• Healthy volunteers: Accepted

Summary

The aim of this randomized, controlled, multi-center, double-blind study of healthy term infants is to test the safety and efficacy of a new infant formula with a specific blend of six human milk oligosaccharides. The primary objective of the trial is to demonstrate the safety of the new infant formula supplemented by comparing the growth of infants randomized to the experimental formula versus the control formula from enrollment to the age of 4 months. The study has an interventional phase up to 6 months of age including 5 visits followed by an observational phase up to 12 months of age for a subgroup of the first 50 breastfed infants and the first 110 formula-fed infants including 2 additional visits.

Conditions

• Healthy Infants

Interventions

Type	Name	Description
OTHER	New infant formula with 6 HMOs blend	Infants are fed with HMO formula from the date of enrollment to the age of 6 months, exclusive formula feeding until the age of 4 months.
OTHER	Standard infant formula without 6 HMOs blend	Infants are fed with standard formula from the date of enrollment to the age of 6 months, exclusive formula feeding until the age of 4 months.

Timeline

• Start date: 2023-11-12
• Primary completion: 2026-05-01
• Completion: 2026-12-01
• First posted: 2023-09-25
• Last updated: 2026-03-17

Locations

5 sites across 1 country: China