An interventional study of Feihe Investigational Formula and Control Formula in Flu and Cold, sponsored by Heilongjiang Feihe Dairy Co. Ltd.. Completed at 3 sites in China. Open to participants aged 1 Day to 28 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-08.
Sponsored by Heilongjiang Feihe Dairy Co. Ltd. · Not applicable, Interventional, and Supportive care
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.
2,356 studies on the registry are indexed under Influenza, Human; 184 are open to participants now.
This study's enrollment of 240 is close to the median of 227 across 1,957 interventional studies indexed under Influenza, Human.
Browse Influenza, Human studies →Heilongjiang Feihe Dairy Co. Ltd. is the lead sponsor of 11 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Dietary Supplement: Feihe Investigational Formula
Control formula contains comparable macronutrients and micronutrients, but does not contain Lactoferrin fortified with HMO
Dietary Supplement: Control Formula
breastmilk-feeding
Other: Breastfeeding
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.
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.
Exclusively breastfed for the first 4 months and continue with supplement food without any marketed infant formula.
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.
Time frame: At the age of 12 months
Weight in grams
The weight measurement (gram) of the participant for each site visit
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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; 1. Hard- dry, hard pellets; 2. Formed- definite shape, not dry; 3. Soft-no definite shape, pasty; 4. Unformed or seedy- no shape, some water or small lumps ; 5. Waterly- no shape, mainly water where the score of 0-1 represents poor stool characteristics, while 2-5 represents fine stool characteristics.
Time frame: 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
Time frame: baseline day to 12 months
Ran from Nov 2023 to primary completion in Apr 2025, 16 months.
Of 166 interventional studies with no phase under Influenza, Human, half reached primary completion within 6 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 16. This study's 16 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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Heilongjiang Feihe Dairy Co. Ltd.