Safety and Nutritional Adequacy of a New Infant Formula in Healthy Term Infants

April 22, 2020 updated by: Heilongjiang Feihe Dairy Co. Ltd.

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

This study is a multicenter, double-blind, randomized, controlled, parallel-designed, prospective study and is intended to evaluate the nutritional adequacy and tolerance of a new study formula compared with a concurrent control formula. Approximately 450 infants will be enrolled from approximately 3 China sites. Of these infants, approximately 300 will be randomized 1:1 to receive an investigational formula or a control formula for 16weeks of feeding. The remaining approximately 150 infants will be enrolled as a breastfeeding reference group. The primary outcome measure is the rate of weight gain in g/day between baseline and 16 weeks in the test group compared to control formula group. Participants will have the option of providing stool samples at 8 weeks and 16 weeks for analysis of microbiota and metabolomics. The study period will be 16 weeks, and all infants in the 2 formula groups will receive formula free of charge for 6 months.

Study Overview

Status

Status

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

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

Primary Objective

1) Compare the rate of weight gain (in g/day) between infants receiving an investigational formula and infants receiving a control formula between at baseline (B), B+2 weeks, B+4 weeks, B+8 weeks, B+12 weeks, and B+16 weeks.

Secondary Objectives

  1. Compare rate of change in length (mm/day) among infants receiving an investigational formula, infants receiving a control formula, and breastfeeding infants at baseline (B), B+2 weeks, B+4 weeks, B+8 weeks, B+12 weeks, and B+16 weeks.
  2. Compare rate of change in head circumference (mm/day) among infants receiving an investigational formula, infants receiving a control formula and breastfeeding infants at baseline (B), B+2 weeks, B+4 weeks, B+8 weeks, B+12 weeks, and B+16 weeks.
  3. Evaluate and compare achieved body weight, length, and head circumference at each visit and after 16 weeks.
  4. Evaluate plotted raw growth data on World Health Organization standard growth charts.1
  5. Compare the types and incidence of adverse events among infants receiving an investigational formula, infants receiving a control formula, and breastfeeding infants.
  6. Compare average daily intake of formula between infants receiving an investigational formula and infants receiving a control formula.
  7. Compare parents' and physician's assessment of formula tolerance among infants receiving an investigational formula, infants receiving a control formula, and breastfeeding infants.
  8. Compare counts of Bifidobacteria and Lactobacillus species in stools of infants receiving an investigational formula, infants receiving a control formula, and breastfeeding infants.
  9. Compare stool short-chain fatty acid metabolites (including total SCFAs, acetic, propionic, n-butyric, iso-butyric and n-valeric acids, L-lactic acid and D-lactic acid, etc) among infants receiving an investigational formula, infants receiving a control formula, and breastfeeding infants.

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 (Anticipated)

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.
450

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 Locations

  • China
    • Zhejiang
      • Jinhua, Zhejiang, China
        • Jinhua Nanyuan Community Health Center (site 1919)
      • Jinhua, Zhejiang, China
        • Jinhua Qiubin Community Health Center (site 1969)
      • Jinhua, Zhejiang, China
        • Jinhua Xiguan Community Health Center (site 1966)

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

1 week to 2 weeks (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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)
  • Birth weight of 2490g to 4200g
  • Signed informed consent obtained for infant's and mother's participation in the study

Exclusion Criteria:

  • 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%]
  • Immunocompromised (according to a doctor's diagnosis of immunodeficiency such as Combined Immunodeficiencies, DiGeorge Syndrome, Wiskott-Aldrich Syndrome, Severe Congenital Neutropenia and Secondary Immunodeficiencies linked to HIV infection, Down Syndrome or others)
  • Known head/brain disease/injury such as microcephaly, macrocephaly or others.
  • Enrollment in another interventional clinical research study while participating in this study

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: Quadruple

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.
Experimental: Test Formula
Feihe Stage 1 infant formula
Dietary supplement: Oral feeding of Feihe Stage 1 infant formula
Oral feeding of Feihe Stage 1 infant formula for 16 weeks
Active Comparator: Control formula
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)
Dietary supplement: Oral feeding of control Stage 1 formula
Oral feeding of control Stage 1 formula for 16 weeks (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))
Other: Breast feeding
Breast fed of human milk
Dietary supplement: Breast feeding
Breast feeding of human milk for 16 weeks

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
Rate of change in body weight (grams/day) from baseline
Time Frame: 2 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks
Rate of change in body weight (grams/day) between baseline and B+2 weeks, B+4 weeks, B+8 weeks, B+12 weeks, and B+16 weeks.
2 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks

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
Rate of change in body length (mm/day) from baseline
Time Frame: 2 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks
Rate of change in length (mm/day) measured between baseline (B) and B+2 weeks, B+4 weeks, B+8 weeks, B+12 weeks, and B+16 weeks.
2 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks
Rate of change in head circumference (mm/day) from baseline
Time Frame: 2 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks
Rate of change in head circumference (mm/day) measured between baseline (B) and B+2 weeks, B+4 weeks, B+8 weeks, B+12 weeks, and B+16 weeks.
2 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks
Achieved body weight
Time Frame: 2 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks
Achieved body weight (grams) at each study visit
2 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks
Achieved body length
Time Frame: 2 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks
Achieved body length (cm) at each study visit
2 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks
Achieved head circumference
Time Frame: 2 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks
Achieved head circumference (cm) at each study visit
2 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks
Percentages of infants in each group who are <10th percentile in weight for age.
Time Frame: 16 weeks
Percentages of infants in each group who are <10th percentile in weight for age.
16 weeks
Percentages of infants in each group who are <10th percentile in length for age.
Time Frame: 16 weeks
Percentages of infants in each group who are <10th percentile in length for age.
16 weeks
Percentages of infants in each group who are <10th percentile in head circumference for age.
Time Frame: 16 weeks
Percentages of infants in each group who are <10th percentile in head circumference for age.
16 weeks
Adverse events rate
Time Frame: 16 weeks
Number and percentages of infants in each group experiencing any adverse events and any serious adverse events
16 weeks
Average daily formula intake
Time Frame: 2 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks
Average daily formula intake volume based on 3-day records kept by parents or care-givers prior to each study visit.
2 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks
Percentage of fussiness
Time Frame: 16 weeks
Percentages of parents in each group reporting fussiness
16 weeks
Percentage of colic
Time Frame: 16 weeks
Percentages of parents in each group reporting colic
16 weeks
Percentage of patterns
Time Frame: 16 weeks
Percentages of parents in each group reporting sleeping patterns
16 weeks
Percentage of cramps
Time Frame: 16 weeks
Percentages of parents in each group reporting cramps
16 weeks
Percentage of regurgitation
Time Frame: 16 weeks
Percentages of parents in each group reporting regurgitation
16 weeks
Stool characteristics
Time Frame: 16 weeks
Score of stool characteristics
16 weeks
Percentage of respiratory manifestations
Time Frame: 16 weeks
Percentages of parents in each group reporting respiratory manifestations
16 weeks
Percentage of dermatologic manifestations
Time Frame: 16 weeks
Percentages of parents in each group reporting dermatologic manifestations
16 weeks
Fecal Bifidobacteria counts
Time Frame: 8 weeks,16 weeks
Total fecal Bifidobacteria counts (mean log10 counts / g wet-weight stool) at 8 weeks and 16 weeks.
8 weeks,16 weeks
Fecal Lactobacillus counts
Time Frame: 8 weeks,16 weeks
Total fecal Lactobacillus counts (mean log10 counts / g wet-weight stool) at 8 weeks and 16 weeks.
8 weeks,16 weeks
Stool short-chain fatty acid
Time Frame: 8 weeks,16 weeks
Total stool short-chain fatty acid metabolites in mg/g dry stool at 8 weeks and 16 weeks.
8 weeks,16 weeks

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.
  • Principal Investigator: Fei Li, PhD, Xinhua Hospital Affiliated To Shanghai Jiaotong University School of Medicine

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.
July 8, 2019

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.
April 19, 2020

Study Completion (Anticipated)

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 30, 2020

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).
July 5, 2019

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.
July 5, 2019

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.
July 9, 2019

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.
April 24, 2020

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.
April 22, 2020

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.
April 1, 2020

More Information

Terms related to this study

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.
  • 18-SM-12-FEIHE-001

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings