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

NCT ID: NCT06158659

Last Updated: 2025-12-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-14
• Study Completion Date: 2025-04-03

Brief 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

Flu; Cold

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

Feihe Investigational Formula

Feihe Investigational Formula

1. With the highest lactoferrin content (more than blue)

2. Contains 2 kinds of HMOs

3. Double probiotic combination

4. Comprehensive nutrition: OPO, DHA&ARA, CPP, nucleotide, choline, inositol, taurine, L-carnitine, GOS, lutein

Group Type: EXPERIMENTAL

Feihe Investigational Formula

Intervention Type: DIETARY_SUPPLEMENT

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.

Control Formula

Control formula contains comparable macronutrients and micronutrients, but does not contain Lactoferrin fortified with HMO

Group Type: ACTIVE_COMPARATOR

Control Formula

Intervention Type: DIETARY_SUPPLEMENT

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.

Breastfeeding

breastmilk-feeding

Group Type: OTHER

Breastfeeding

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: 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.

Intervention Type: DIETARY_SUPPLEMENT

Breastfeeding

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Newborn baby, study entry before weaning (within 28 days of birth)
• Exclusively formula fed for at least 3 days prior to study entry and plan to be exclusively formula fed during the study (formula groups) OR plan to be exclusively fed with human milk during the study (breastfeeding group).
• Gestational age of 37-42 weeks (36 weeks and six days is considered 36 weeks gestational age).
• Birth weight of 2500g (5 lbs. 8 oz.) to 4200g (9 lbs. 4 oz.).
• Signed informed consent obtained for infant's participation in the study.
• Parent or guardian of the infant agrees to not enroll the infant in another interventional clinical research study while participating in this study.

Exclusion Criteria

• History of underlying metabolic or chronic disease; congenital malformation; or any other condition which, in the opinion of the Investigator, is likely to interfere with: the ability of the infant to ingest food, the normal growth and development of the infant, or the evaluation of the infant.
• Evidence of feeding difficulties or formula intolerance, such as vomiting or poor intake, at time of randomization (at investigator discretion).
• Evidence of growth problems or concern for growth.
• Infant was born large for gestational age (LGA) (defined as birth weight-for-age exceeding 90th percentile as plotted on the growth chart provided by Feihe) from mother who was diabetic at childbirth.
• Participant is immunocompromised (according to a doctor's diagnosis of immunodeficiency such as Combined Immunodeficiencies, DiGeorge Syndrome, Wiskott-Aldrich Syndrome, Severe Congenital Neutropenia and Secondary Immunodeficiencies linked to HIV infection, Down Syndrome or others) and children with known head/brain disease/injury.
• Use of probiotics/prebiotics before the study.

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 28 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Heilongjiang Feihe Dairy Co. Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Weimin Zhang, MD

Role: PRINCIPAL_INVESTIGATOR

China National Center for Food Safety Risk Assessment Beijing, China

Locations

Jinhua Nanyuan Community Health Center

Jinhua, Zhejiang, China

Li Pu Community Hospital

Jinhua, Zhejiang, China

Qiu Bin Community Hospital

Jinhua, Zhejiang, China

Countries

China

Other Identifiers

22-SM-11-FEIHE-002

Identifier Type: -

Identifier Source: org_study_id