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HealthyNCT06569797

Effect of a Multinutrient-Optimized Infant Formula Supplemented With Human Milk Oligosaccharides on Infant Growth and Development: A Multicenter, Randomized, Controlled Trial

A study testing Human Milk Oligosaccharide-Supplemented, Multi-Nutrient Optimized Infant Formula, Commercially Available Standard Formula and Breast Milk Feeding in people with Healthy, run by Heilongjiang Feihe Dairy Co. Ltd. at 6 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study aims to learn about a newly developed infant formula that adds two special ingredients found in breast milk (human milk oligosaccharides, HMOs) and improves other nutrients. Read more about this study

Who is it for?
Ages 0 to 28 daysHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Human Milk Oligosaccharide-Supplemented, Multi-Nutrient Optimized Infant Formula, Commercially Available Standard Formula and Breast Milk Feeding
Could I receive a placebo?
No, everyone receives an active treatment
How many people
240 participants
Where
6 sitesChina
Study dates
11 Jan 2024to 16 Dec 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 0 to 28 days
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

China6 sites

  • Seventh Medical Center, Chinese PLA General Hospital

    Beijing, Beijing Municipality, 100010

  • Changzhou Second People's Hospital

    Changzhou, Jiangsu, 213000

  • Linyi City Maternal and Child Health Care Hospital

    Linyi, Shandong, 276016

  • Nanjing Medical University

    Nanjin, Jiangsu, 211100

  • The Second Affiliated Hospital of Nanjing Medical University

    Nanjing, Jiangsu, 210003

  • The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine

    Tianjin, Tianjin Municipality, 300381

Other trials in China

About this study

Official title: Effect of Adding Breast Milk Oligosaccharides and Multinutrient Optimized Infant Formula on the Growth and Development of Infants Aged 0 to 1 Years: a Multicenter, Double-blind, Randomized, Controlled Trial

This study aims to learn about a newly developed infant formula that adds two special ingredients found in breast milk (human milk oligosaccharides, HMOs) and improves other nutrients. We will compare the effects of this new formula, a currently available standard formula, and breastfeeding on babies' growth and development during their first year of life. We plan to enroll about 240 healthy newborn babies, who will be divided into three groups: about 80 babies will be fed the new formula with added breast milk ingredients, about 80 will receive the standard infant formula, and about 80 will be breastfed by their mothers. Assignment to the formula groups will be done randomly by computer, while families who wish to and are able to breastfeed will join the breastfeeding group. The study will last about 12 months, during which our research team will have 4 visits with the babies at 28 days, 3 months, 6 months, and 12 months of age. At these visits, we will measure the baby's growth (like height, weight, and head size), use internationally recognized tests to check mental and motor development, collect small samples of stool and blood to understand gut health and immune function, and ask parents to fill out short questionnaires about feeding, sleep, fussiness, and the baby's health. Both formulas used in the study meet national food safety standards, and the entire study follows strict ethical rules to protect the privacy and rights of babies and families. Families in the formula groups will receive all study formula for free and receive regular health check-ups from a professional team. The results will help scientists and doctors better understand how to improve infant formula to support healthy baby growth.

Read the detailed description

This multicenter, randomized, double-blind, controlled, parallel-group clinical trial is designed to evaluate the effects of an investigational infant formula. The formula is supplemented with two key human milk oligosaccharides (HMOs), and further optimized with a nutrient profile, comparing its effects against a standard infant formula. A breastfed reference cohort is included for contextual comparison. The primary objective is to compare the test and control formulas' impact on infant gut health, specifically assessed through gut microbiota composition (via 16S rRNA sequencing) and short-chain fatty acid profiles in stool samples. Secondary objectives involve comparing groups across a range of outcomes: growth parameters (weight, length, head circumference); immune function (serum hsCRP, lymphocyte subsets; fecal sIgA); bone development markers (osteocalcin, alkaline phosphatase); cognitive development (Bayley Scales of Infant and Toddler Development, 4th Edition); metabolic markers (serum amino acids, albumin); and measures of gastrointestinal tolerance, sleep patterns, fussiness, and the incidence of diarrhea and upper respiratory infections. The study will enroll 240 healthy, term infants aged 0-28 days, with key eligibility criteria including singleton birth, gestational age of 37-42 weeks, and birth weight of 2500-4000g. Of these, 160 infants will be centrally randomized (1:1, stratified by site and infant sex) to receive either the test or control formula under double-blind conditions, while the remaining infants will form a non-randomized, open-label breastfed group. The intervention period spans 360 days, with protocol-defined minimum daily feeding requirements for each group. Outcomes will be assessed during scheduled visits at Day 28, Day 90±3, Day 180±5, and Day 360±7, encompassing anthropometry, neurodevelopmental testing (final visit), biosample (stool/blood) collection, and questionnaires.

Conditions
Healthy
Being tested
Human Milk Oligosaccharide-Supplemented, Multi-Nutrient Optimized Infant Formula, Commercially Available Standard Formula, Breast Milk Feeding
Keywords
Milk oligosaccharides, multiple nutrients, infants

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Human Milk Oligosaccharide-Supplemented, Multi-Nutrient Optimized Infant FormulaDietary supplement

    This is an investigational infant formula designed to be closer to the nutritional and functional composition of breast milk. It is distinguished by the addition of a specific, proprietary blend of human milk oligosaccharides (HMOs) and a comprehensively optimized nutrient profile. The optimization encompasses multiple key nutrient categories (including proteins, lipids, prebiotics/probiotics, and micronutrients) aimed at supporting infant gut health, immune development, and overall growth.

  • Commercially Available Standard FormulaDietary supplement

    A commercially available standard infant formula, administered as the control. It does not contain the human milk oligosaccharides (HMOs) or other specific nutrient optimizations present in the investigational formula.

  • Breast Milk FeedingDietary supplement

    Participants are breastfed by their mothers, receiving human breast milk as the sole or primary source of nutrition. It serves as a natural benchmark for comparing growth, development, and health outcomes against infants fed the investigational or standard formulas.

Study groups in NCT06569797
Study groupRoleWhat they receive
experimental groupExperimentalIntervention with a novel infant formula containing added human milk oligosaccharides and a multi-nutrient optimized profile
Receives: Dietary Supplement: Human Milk Oligosaccharide-Supplemented, Multi-Nutrient Optimized Infant Formula
control groupActive comparatorFeeding with regular infant formula milk powder
Receives: Dietary Supplement: Commercially Available Standard Formula
Breastfeeding groupActive comparatorBreastfeeding with breast milk
Receives: Dietary Supplement: Breast Milk Feeding

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Intestinal indicators

    16s rRNA

    Measured: day 28,180

  2. Intestinal indicators

    SCFAs

    Measured: day 28,180

Secondary outcomes (21)

  1. Inflammatory markers

    serum hsCRP

    Measured: day 180,360

  2. Nutritional indicators

    serum albumin

    Measured: day 180,360

  3. Immune indicators

    fecal sIgA

    Measured: day 28,180

  4. Immune indicators

    blood lymphocyte subsets

    Measured: day 180,360

  5. Growth and development indicators

    height

    Measured: day 28,90,180,360

  6. Growth and development indicators

    weight

    Measured: day 28,90,180,360

  7. Growth and development indicators

    head circumference

    Measured: day 28,90,180,360

  8. Growth and development indicators

    chest circumference

    Measured: day 28,90,180,360

  9. Bone development indicators

    osteocalcin

    Measured: day 180,360

  10. Bone development indicators

    alkaline phosphatase

    Measured: day 180,360

  11. Tolerance indicators

    investigation of infant gastrointestinal comfort：In the past week, the average daily number of reflux .The minimum number is 0, and there is no limit to the maximum number.

    Measured: day 28,90,180,360

  12. Tolerance indicators

    Infant Gastrointestinal Comfort Score：A score assessing the comfort level related to gastrointestinal symptoms over the past week.The minimum score is 0, and the maximum score is 10.

    Measured: day 28,90,180,360

  13. Tolerance indicators

    investigation of infant sleep crying：In the past week, the average daily crying time.The minimum time is 0 hours and the maximum time is 24 hours.

    Measured: day 28,90,180,360

  14. Tolerance indicators

    investigation of infant sleep crying：In the past week, the average daily crying frequency.The minimum number of times is 0, and the maximum number of times is unlimited.

    Measured: day 28,90,180,360

  15. Tolerance indicators

    investigation of infant sleep crying：In the past week, the average daily crying severity. The severity of crying is divided into no crying, mild crying, moderate crying, very crying, and extreme crying.

    Measured: day 28,90,180,360

  16. Tolerance indicators

    investigation of infant sleep crying：In the past week, the average daily crying daytime and nighttime sleep duration. The minimum time is 0 hours and the maximum time is 12 hours.

    Measured: day 28,90,180,360

  17. Tolerance indicators

    investigation of infant sleep crying：In the past week, sleep problems of infants.Sleep problems are divided into no problem, minor problem, moderate problem, major problem, and extreme problem.

    Measured: day 28,90,180,360

  18. Tolerance indicators

    investigation of infant diarrhea and upper respiratory tract infections：The severity of diarrhea and upper respiratory tract infections (colds) in infants from birth until now. The severity level is classified as no problem, minor problem, moderate problem, major problem, and maximum problem.

    Measured: day 28,90,180,360

  19. Tolerance indicators

    Bristol stool classification of infant feces

    Measured: day 28,180

  20. Cognitive Development

    Bailey Infant Development Scale (Version IV) Score（130 or above, very excellent; 120-129, excellent; 110~119, upper middle; 90-109, moderate; 80-89, below average; 70-79, critical state; Below 69, developmental delay）

    Measured: day 360

  21. Cognitive Development

    Serum Amino Acids

    Measured: day 180,360

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Aug 2024
  2. Study start11 Jan 2024
  3. Primary completion16 Dec 2025
  4. Study completion16 Dec 2025

Resources

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
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Model description
multicenter, double-blind, randomized, controlled trial
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
240 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06569797
Sponsor's protocol ID
CTS-MP-2023-01
Status last verified
Jul 2026
First submitted
7 Aug 2024
Last updated
21 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Human Milk Oligosaccharide-Supplemented, Multi-Nutrient Optimized Infant Formula, Commercially Available Standard Formula and Breast Milk Feeding in people with Healthy, run by Heilongjiang Feihe Dairy Co. Ltd. at 6 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 16 inclusion and 10 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 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 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?

Intestinal indicators (time frame: day 28,180). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06569797.

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 21 Jul 2026.

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