FluNCT06158659
Improved Immunology Outcomes Associated With Lactoferrin Fortified With HMO in Infant Formula
A study testing Feihe Investigational Formula and Breastfeeding in people with Flu and Cold, run by Heilongjiang Feihe Dairy Co. Ltd. at 3 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 28 daysHealthy volunteers can take part
- What is being tested?
- Feihe Investigational Formula and Breastfeeding
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 3 sitesChina
- Study dates
- 14 Nov 2023to 3 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 28 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
China3 sites
Jinhua Nanyuan Community Health Center
Jinhua, Zhejiang
Li Pu Community Hospital
Jinhua, Zhejiang
Qiu Bin Community Hospital
Jinhua, Zhejiang
About this study
Official title: Improved Immunology Outcomes Associated With Feihe Lactoferrin Fortified With HMO in Infant Formula: A Randomized, Controlled Trial
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.
Read more
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.
- Being tested
- Feihe Investigational Formula, Control Formula, Breastfeeding
- Keywords
- infant formula, lactoferrin, HMO (Human Milk Oligosaccharides), immunology
- Medical subject headings
- Influenza, Human, Common Cold
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Feihe Investigational FormulaDietary 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 FormulaDietary 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.
BreastfeedingOther
Exclusively breastfed for the first 4 months and continue with supplement food without any marketed infant formula.
| Study group | Role | What they receive |
|---|---|---|
| Feihe Investigational Formula | Experimental | 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 Receives: Dietary Supplement: Feihe Investigational Formula |
| Control Formula | Active comparator | Control formula contains comparable macronutrients and micronutrients, but does not contain Lactoferrin fortified with HMO Receives: Dietary Supplement: Control Formula |
| Breastfeeding | Other | breastmilk-feeding Receives: Other: Breastfeeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of flu and cold during the study
Frequency of flu and cold that participants caught during the study, which has positive relationship with immunology outcomes.
Measured: At the age of 12 months
Secondary outcomes (6)
Weight in grams
The weight measurement (gram) of the participant for each site visit
Measured: At the age of 15-28 days and 3, 6, 9, 12 months]
Height in cm
The height measurement (cm) of the participant for each site visit
Measured: At the age of 15-28 days and 3, 6, 9, 12 months
Head circumference in cm
The head circumference measurement (cm) of the participant for each site visit
Measured: At the age of 15-28 days and 3, 6, 9, 12 months
Amount of formula intake in ml
The 24-Hour dietary recall of Formula intake (amount in ml of study formula, any other infant formula or milk consumed) of the participant for each site visit
Measured: At the age of 15-28 days and 3, 6, 9, 12 months
Stool Characteristics Questionnaire
The frequency of bowel movements and the rating score (0-5) of the stool consistency over the 24-hour period. The rating score of the stool consistency from the stool picture:
0-No bowel movement;
- Hard- dry, hard pellets;
- Formed- definite shape, not dry;
- Soft-no definite shape, pasty;
- Unformed or seedy- no shape, some water or small lumps ;
- Waterly- no shape, mainly water where the score of 0-1 represents poor stool characteristics, while 2-5 represents fine stool characteristics.
Measured: At the age of 15-28 days and 3, 6 months
Medically-confirmed adverse events
The frequency of medically-confirmed adverse events occurred during the study
Measured: baseline day to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2023
- Study start14 Nov 2023
- Primary completion3 Apr 2025
- Study completion3 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FluStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heilongjiang Feihe Dairy Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Weimin Zhang, MD, Principal investigator, China National Center for Food Safety Risk Assessment Beijing, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06158659
- Sponsor's protocol ID
- 22-SM-11-FEIHE-002
- Status last verified
- Dec 2025
- First submitted
- 26 Nov 2023
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improved Immunology Outcomes Associated With Feihe Lactoferrin Fortified With HMO in Infant Formula: A Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT06158659
- Acronym / sponsor ID
- 22-SM-11-FEIHE-002
- Keywords
- infant formula, lactoferrin, HMO (Human Milk Oligosaccharides), immunology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Heilongjiang Feihe Dairy Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 14 Nov 2023 (actual)
- Primary completion
- 3 Apr 2025 (actual)
- Study completion
- 3 Apr 2025 (actual)
- First posted
- 6 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Feihe Investigational Formula | Experimental | Dietary Supplement: Feihe Investigational FormulaFeihe 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 |
| Control Formula | Active comparator | Dietary Supplement: Control FormulaControl formula contains comparable macronutrients and micronutrients, but does not contain Lactoferrin fortified with HMO |
| Breastfeeding | Other | Other: Breastfeedingbreastmilk-feeding |
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Feihe Investigational FormulaParticipants 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 | Feihe Investigational Formula |
| Control FormulaParticipants 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. | Dietary supplement | Control Formula |
| BreastfeedingExclusively breastfed for the first 4 months and continue with supplement food without any marketed infant formula. | Other | Breastfeeding |
Primary outcome
Frequency of flu and cold during the study
Time frame: At the age of 12 months
Frequency of flu and cold that participants caught during the study, which has positive relationship with immunology outcomes.
6 secondary outcomes
Weight in grams
Time frame: At the age of 15-28 days and 3, 6, 9, 12 months]
Height in cm
Time frame: At the age of 15-28 days and 3, 6, 9, 12 months
Head circumference in cm
Time frame: At the age of 15-28 days and 3, 6, 9, 12 months
Amount of formula intake in ml
Time frame: At the age of 15-28 days and 3, 6, 9, 12 months
Stool Characteristics Questionnaire
Time frame: At the age of 15-28 days and 3, 6 months
Medically-confirmed adverse events
Time frame: baseline day to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Weimin Zhang, MD principal investigator
China National Center for Food Safety Risk Assessment Beijing, China
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Feihe Investigational Formula and Breastfeeding in people with Flu and Cold, run by Heilongjiang Feihe Dairy Co. Ltd. at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of flu and cold during the study (time frame: At the age of 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2025.