MedTrace Logo

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

NCT06053112 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 326

Last updated 2026-03-17

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Merieux NutriSciences (China)

    collaborator UNKNOWN

  • Junlebao Dairy Group Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Wei CAI, MD, Ph.D. · Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Max Age
14 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-11-12
Primary Completion
2026-05-31
Completion
2026-12-31

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06053112 on ClinicalTrials.gov