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

July 17, 2026 updated by: Heilongjiang Feihe Dairy Co. Ltd.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
240

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100010
        • Seventh Medical Center, Chinese PLA General Hospital
    • Jiangsu
      • Changzhou, Jiangsu, China, 213000
        • Changzhou Second People's Hospital
      • Nanjin, Jiangsu, China, 211100
        • Nanjing Medical University
      • Nanjing, Jiangsu, China, 210003
        • The Second Affiliated Hospital of Nanjing Medical University
    • Shandong
      • Linyi, Shandong, China, 276016
        • Linyi City Maternal and Child Health Care Hospital
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300381
        • The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: control group
Feeding with regular infant formula milk powder
Dietary supplement: Commercially Available Standard Formula
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.
Active Comparator: Breastfeeding group
Breastfeeding with breast milk
Dietary supplement: Breast Milk Feeding
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.
Experimental: experimental group
Intervention with a novel infant formula containing added human milk oligosaccharides and a multi-nutrient optimized profile
Dietary supplement: Human Milk Oligosaccharide-Supplemented, Multi-Nutrient Optimized Infant Formula
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Intestinal indicators
Time Frame: day 28,180
16s rRNA
day 28,180
Intestinal indicators
Time Frame: day 28,180
SCFAs
day 28,180

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Inflammatory markers
Time Frame: day 180,360
serum hsCRP
day 180,360
Nutritional indicators
Time Frame: day 180,360
serum albumin
day 180,360
Immune indicators
Time Frame: day 180,360
blood lymphocyte subsets
day 180,360
Growth and development indicators
Time Frame: day 28,90,180,360
height
day 28,90,180,360
Growth and development indicators
Time Frame: day 28,90,180,360
weight
day 28,90,180,360
Growth and development indicators
Time Frame: day 28,90,180,360
head circumference
day 28,90,180,360
Growth and development indicators
Time Frame: day 28,90,180,360
chest circumference
day 28,90,180,360
Bone development indicators
Time Frame: day 180,360
osteocalcin
day 180,360
Bone development indicators
Time Frame: day 180,360
alkaline phosphatase
day 180,360
Tolerance indicators
Time Frame: day 28,90,180,360
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.
day 28,90,180,360
Tolerance indicators
Time Frame: day 28,90,180,360
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.
day 28,90,180,360
Tolerance indicators
Time Frame: day 28,90,180,360
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.
day 28,90,180,360
Tolerance indicators
Time Frame: day 28,90,180,360
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.
day 28,90,180,360
Tolerance indicators
Time Frame: day 28,90,180,360
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.
day 28,90,180,360
Tolerance indicators
Time Frame: day 28,90,180,360
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.
day 28,90,180,360
Tolerance indicators
Time Frame: day 28,90,180,360
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.
day 28,90,180,360
Cognitive Development
Time Frame: day 180,360
Serum Amino Acids
day 180,360
Immune indicators
Time Frame: day 28,180
fecal sIgA
day 28,180
Tolerance indicators
Time Frame: day 28,90,180,360
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.
day 28,90,180,360
Tolerance indicators
Time Frame: day 28,180
Bristol stool classification of infant feces
day 28,180
Cognitive Development
Time Frame: day 360
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）
day 360

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
adverse event
Time Frame: From enrollment until the end of the study (Day 360), up to 12 months
adverse event
From enrollment until the end of the study (Day 360), up to 12 months
Serious adverse events
Time Frame: From enrollment until the end of the study (Day 360), up to 12 months
Serious adverse events
From enrollment until the end of the study (Day 360), up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Heilongjiang Feihe Dairy Co. Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Zhixu Wang, Nanjing Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 11, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 16, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 16, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 7, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 21, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 26, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 21, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 17, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CTS-MP-2023-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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