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The Trial of a New Infant Formula in Healthy Term Chinese Infants
Sponsor: Junlebao Dairy Group Co., Ltd.
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.
Official title: Safety and Efficacy of Infant Formula Containing a Specific Blend of Six Human Milk Oligosaccharides: A Double-blind, Randomized, Controlled Trial
Key Details
Gender
All
Age Range
Any - 14 Days
Study Type
INTERVENTIONAL
Enrollment
326
Start Date
2023-11-12
Completion Date
2026-12
Last Updated
2026-03-17
Healthy Volunteers
Yes
Conditions
Interventions
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.
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.
Locations (5)
Affiliated Hospital of Jining Medical College
Jining, China
Shanghai Public Health Clinical Center affiliated to Fudan University
Shanghai, China
Xinhua Hospital affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, China
The Third People's Hospital affiliated to Hebei Medical University
Shijiazhuang, China
The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Tianjin, China