Baby formula with immune boosters may cut colds and flu in infants
NCT ID NCT06158659
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested whether a special infant formula containing lactoferrin and human milk oligosaccharides (HMOs) could improve immunity in newborns. 240 healthy full-term babies were randomly assigned to receive either the test formula, a standard formula, or breast milk for 12 months. Researchers tracked how often the babies caught colds or the flu to see if the test formula made a difference.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- lactoferrin and human milk oligosaccharides (HMOs) added to infant formula
- What this could lead to
- If it works, this could point toward a way to strengthen babies' immune systems through formula, potentially reducing common infections like colds and flu.
- What could go wrong
- This is a completed early-stage study with 240 participants, so results may not apply to all babies. The effect on immunity is measured by infection frequency, which can vary widely, and the formula is not a treatment for existing illness.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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240 people
The number who actually took part.
- Started
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Nov 2023
- Finished
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Apr 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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1 day to 28 days
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Jinhua Nanyuan Community Health Center
Jinhua, Zhejiang, China
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Li Pu Community Hospital
Jinhua, Zhejiang, China
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Qiu Bin Community Hospital
Jinhua, Zhejiang, China
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