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

NCT06569797 | Completed

• 1 other identifier: CTS-MP-2023-01
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 6

Brief 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. 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.

Conditions

Healthy

Keywords

Milk oligosaccharides; multiple nutrients; infants

Outcome Measures

Primary Outcomes (2)

• Intestinal indicators

  16s rRNA

  day 28,180

• Intestinal indicators

  SCFAs

  day 28,180

Secondary Outcomes (21)

• Inflammatory markers

  day 180,360

• Nutritional indicators

  day 180,360

• Immune indicators

  day 28,180

• Immune indicators

  day 180,360

• Growth and development indicators

  day 28,90,180,360

Other Outcomes (2)

• adverse event

  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

Study Arms (3)

experimental group

EXPERIMENTAL

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

control group

ACTIVE COMPARATOR

Feeding with regular infant formula milk powder

Dietary Supplement: Commercially Available Standard Formula

Breastfeeding group

ACTIVE COMPARATOR

Breastfeeding with breast milk

Dietary Supplement: Breast Milk Feeding

Interventions

Commercially Available Standard Formula DIETARY_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.

control group

Breast Milk Feeding DIETARY_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.

Breastfeeding group

Human Milk Oligosaccharide-Supplemented, Multi-Nutrient Optimized Infant Formula DIETARY_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.

experimental group

Eligibility Criteria

• Age: 0 Days - 28 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Heilongjiang Feihe Dairy Co. Ltd.: lead

Study Sites (6)

Seventh Medical Center, Chinese PLA General Hospital

Beijing, Beijing Municipality, 100010, China

Location

Changzhou Second People's Hospital

Changzhou, Jiangsu, 213000, China

Location

Nanjing Medical University

Nanjin, Jiangsu, 211100, China

Location

The Second Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210003, China

Location

Linyi City Maternal and Child Health Care Hospital

Linyi, Shandong, 276016, China

Location

The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine

Tianjin, Tianjin Municipality, 300381, China

Location

Study Officials

• Zhixu Wang

  Nanjing Medical University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: This clinical study is a double-blind trial, and before unblinding, neither the researchers nor the subjects know whether they belong to the experimental group or the control group
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: multicenter, double-blind, randomized, controlled trial

Study Record Dates

• First Submitted: August 7, 2024
• First Posted: August 26, 2024
• Study Start: January 11, 2024
• Primary Completion: December 16, 2025
• Study Completion: December 16, 2025
• Last Updated: July 21, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (6)