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LL-37

Cathelicidin, hCAP-18, FALL-39, CAP-18

Quick Stats
Studies 2230
Trials 95
Recruiting NA INTERVENTIONAL NCT06053112

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

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief 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.

Interventions

Name: New infant formula with 6 HMOs blend
Type: OTHER
Description: 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.
Name: Standard infant formula without 6 HMOs blend
Type: OTHER
Description: 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.

Primary Outcomes

Measure: Weight gain (g/day) between enrollment and the age of 4 months
TimeFrame: until the age of 4 months
Description:

Trial Information

NCT ID

NCT06053112

Status

Recruiting

Study Type

INTERVENTIONAL

Phases

NA

Sponsor

Junlebao Dairy Group Co., Ltd.

Last Updated

December 15, 2025