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Improved Immunology Outcomes Associated With Lactoferrin Fortified With HMO in Infant Formula

NCT06158659 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2025-12-08

No results posted yet for this study

Summary

The goal of this interventional clinical trial is to test the effectiveness of enhancing immunity in newly born infants fed with Feihe investigational formula product containing Lactoferrin fortified with HMO. The main question it aims to answer is:

\- whether the immunity functions of participants in terms of frequency of catching flu and cold in the study product arm is significantly better than participants assigned in the other two arms.

240 qualified participants will be randomized to 3 arms (investigational formula, control formula, and breast-feeding) to consume assigned formula or breast-feeding for 12 months according to protocol. There will be up to 6 site visits arranged for each participant during the study, and all relevant clinical and questionnaire data, including the most important primary outcome - frequency of catching flu and cold for each visit interval, will be captured, recorded and entered to CMTS (Clinical Management Trial System) for statistical analysis and reporting.

Researchers will compare the three arms to validate the assumption that the consumption of Feihe investigational formula product containing Lactoferrin fortified with HMO will improve immunity in newly born infants, along with physical development.

Conditions

Interventions

DIETARY_SUPPLEMENT

Feihe Investigational Formula

Participants in this arm will receive stage 1 and stage 2 Feihe investigational formulas. At the first (up to) 6 months, they will be fed with stage1 formula, and then switch to stage 2 formula until 12 months.

DIETARY_SUPPLEMENT

Control Formula

Participants in this arm will receive stage 1 and stage 2 Control formulas. At the first (up to) 6 months, they will be fed with stage1 formula, and then switch to stage 2 formula until 12 months.

OTHER

Breastfeeding

Exclusively breastfed for the first 4 months and continue with supplement food without any marketed infant formula.

Sponsors & Collaborators

  • Heilongjiang Feihe Dairy Co. Ltd.

    lead INDUSTRY

Principal Investigators

  • Weimin Zhang, MD · China National Center for Food Safety Risk Assessment Beijing, China

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
28 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-11-14
Primary Completion
2025-04-03
Completion
2025-04-03

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT06158659 on ClinicalTrials.gov