Could a formula closer to breast milk boost baby development?
NCT ID NCT06569797
First seen Jul 21, 2026 · Last updated Jul 22, 2026 · Updated 1 time
Summary
This study compares a new infant formula that includes human milk oligosaccharides (special sugars found in breast milk) and a blend of optimized nutrients against standard formula and breastfeeding. About 240 healthy newborns will be followed for their first year, with measurements of growth, mental and motor development, and gut health. The goal is to see if this enhanced formula can better support infant development.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a new infant formula with added human milk oligosaccharides and optimized nutrients
- What this could lead to
- If successful, this formula could help bridge the nutritional gap between standard formula and breast milk, potentially supporting better growth and gut health in formula-fed infants.
- What could go wrong
- This is an early-stage study with only 240 babies, so results may not apply to all infants. The new formula may not show clear benefits over standard formula or breastfeeding.
This is an AI summary of the original study and may miss details. Read our disclaimer.
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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Jan 2024
- Finished
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Dec 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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0 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: Breastfed Group Infants eligible for the breastfed reference group must meet all of the following criteria: * Aged 0 to 28 days after birth (inclusive). * Singleton birth. * Gestational age between 37 and 42 weeks (inclusive). * Birth weight between 2500 and 4000 grams (inclusive). * Parent(s) or legal guardian(s) agree that the infant will not participate in any other interventional clinical studies for the duration of this trial. * Parent(s) or legal guardian(s) agree to feed the infant according to the trial protocol (i.e., breastfeeding). Formula-fed Group Infants eligible for the randomized formula-fed groups must meet all of the following criteria: * Aged 0 to 28 days after birth (inclusive). * Singleton birth. * Gestational age between 37 and 42 weeks (inclusive). * Birth weight between 2500 and 4000 grams (inclusive). * Parent(s) or legal guardian(s) agree that the infant will not participate in any other interventional clinical studies for the duration of this trial. * Parent(s) or legal guardian(s) agree to feed the infant according to the trial protocol. * For objective or subjective reasons, the mother is unable to provide exclusive breastfeeding. Exclusion Criteria: Infants will be excluded from the trial if they meet any of the following criteria: * Conceived through assisted reproductive technology. * Maternal history of any condition during pregnancy known to compromise intrauterine growth. * Maternal history of gestational diabetes, significant metabolic disease, or chronic disease during pregnancy. * Presence of congenital malformations, genetic disorders, chronic diseases, or congenital conditions that could interfere with the study participation or outcome assessments. * Known IgE-mediated cow's milk protein allergy, or presence of factors that increase the risk of cow's milk protein allergy. * Active acute infection or gastroenteritis at the time of enrollment. * History of functional gastrointestinal disorders, such as gastroparesis. * Concurrent participation in another clinical trial. * Any condition that, in the investigator's judgment, could compromise the parent's willingness or ability to comply with the protocol requirements.
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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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Changzhou Second People's Hospital
Changzhou, Jiangsu, 213000, China
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Linyi City Maternal and Child Health Care Hospital
Linyi, Shandong, 276016, China
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Nanjing Medical University
Nanjin, Jiangsu, 211100, China
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Seventh Medical Center, Chinese PLA General Hospital
Beijing, Beijing Municipality, 100010, China
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The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Tianjin, Tianjin Municipality, 300381, China
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The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210003, China
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