Suspended

Investigational Formula Safety and Nutritional Adequacy in Healthy Term Infants

What is being tested

Oral feeding of Feihe Stage 1 infant formula

+ Oral feeding of control Stage 1 formula

+ Breast feeding

Dietary Supplement

Who is being recruted

+13 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Basic Science Study

Interventional

Study Start: July 2019

See protocol details

Summary

Principal SponsorHeilongjiang Feihe Dairy Co. Ltd.

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: July 8, 2019

Actual date on which the first participant was enrolled.

This study focuses on healthy term infants, aiming to evaluate the safety and nutritional adequacy of a new infant formula. The primary goal is to compare the rate of weight gain in infants receiving this new formula with those receiving a control formula. This research is important as it could lead to improved nutritional options for infants, ensuring they receive the best possible start in life. During the study, infants will receive either the investigational formula or the control formula. Their rate of weight gain, change in length, and head circumference will be measured at various intervals over a 16-week period. The study also evaluates the types and incidence of adverse events, average daily intake of formula, and formula tolerance. It compares the counts of certain bacteria and acid metabolites in the stools of infants receiving the new formula, control formula, and breastfeeding infants. These measurements help determine the safety and effectiveness of the new formula.

Official TitleRandomized, Double-blind, Parallel, Controlled Study to Evaluate the Safety and Nutritional Adequacy of a New Infant Formula in Healthy Term Infants

NCT04013087

Principal SponsorHeilongjiang Feihe Dairy Co. Ltd.

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

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

Design Details

450 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Basic Science Study

Basic science studies help researchers understand how the body works or how a disease develops. They don't test treatments, but they build the foundation for future therapies.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

6 inclusion criteria required to participate

10-14 days of age at enrolment and randomization, inclusive (day of birth is considered day 0)

Plan to exclusively formula feed (formula groups) OR exclusively feed human milk (breastfeeding group)

Healthy singleton birth

Gestational age of 37-42 completed weeks (37 weeks 0 days through 42 weeks 6 days)

Show More Criteria

7 exclusion criteria prevent from participating

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)

Known allergy to cow's milk protein or a well-documented family history of allergy to cow's milk protein

Weight at randomization is <90% of birth weight [(weight at Visit 1÷birth weight) x 100 <90%]

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Feihe Stage 1 infant formula

Group II

Active Comparator

A commercially available product with comparable composition but does not contain sn-2 palmitate enriched vegetable oil as an ingredient (regular vegetable oil is used)

Group III

Breast fed of human milk

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 3 locations

Suspended

Jinhua Nanyuan Community Health Center (site 1919)

Jinhua, ChinaOpen Jinhua Nanyuan Community Health Center (site 1919) in Google Maps

Suspended

Jinhua Qiubin Community Health Center (site 1969)

Jinhua, China

Suspended

Jinhua Xiguan Community Health Center (site 1966)

Jinhua, China

Suspended3 Study Centers