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ACTIVE NOT RECRUITING
NCT06053112
NA

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

Sponsor: Junlebao Dairy Group Co., Ltd.

View on ClinicalTrials.gov

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

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.

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