Effects of an Infant Formula on Growth, Safety and Efficacy for Healthy Term Infants

May 13, 2024 updated by: Bunge Loders Croklaan

Comparative Effects of Cow's Milk Based Infant Formula Containing Both OPO and CPP Versus Non-OPO Formula and Breast Feeding on Growth, Stool Consistency and Bone Strength: A Double-blinded, Randomized and Controlled Study

The purpose of this study is to evaluate that a Cow's Milk Based Infant Formula A2 Containing Both OPO and CPP for healthy term infants supports age-appropriate growth. In this randomized, controlled trial (RCT), healthy, term, formula-fed (FF) infants will be randomized to one of two infant formulas: a standard, commercially-available infant formula for term infants (CF) or the study formula for term infants (SF) for 16 weeks. A reference group of human milk-fed infants will also be enrolled. The primary objective is to compare the growth, tolerance, stool consistency and bone strength of infants randomized to the study infant formula (SF) versus infants randomized to the standard commercial infant formula (CF).

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 study is a randomized, controlled, double-blind, study of healthy term formula fed (FF) infants. FF infants will be randomized to receive either a study infant formula, formulated for healthy term infants or a commercially available infant formula for healthy term infants. Infants will consume the formula for a total of 16-weeks; infant growth, tolerance, stool consistency and bone strength will be assessed throughout the study.

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.
180

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 Locations

  • China
      • Jinhua, China
        • JiangNan Street Community Health Service Center, WuCheng District
      • Jinhua, China
        • QiuBin Street Community Health Service Center, WuCheng District

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

2 weeks to 1 month (Child)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 30 days of age at randomization, inclusive (day of birth is considered day 0)
  • Exclusively formula-fed or partially bottle feeding with intake more than 650 ml /day for at least 3 days prior to randomization
  • Exclusively breast fed for at least 7 days prior to randomization
  • Singleton birth
  • Gestational age of 37-42 weeks (36 weeks and six days is considered 36 weeks of gestational age)
  • Birth weight of 2500g to 4000g
  • Signed informed consent obtained for infant's participation in the study
  • Parent or guardian of infant agrees not to enroll infant in another interventional clinical research study while participating in this 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)
  • Weight at Visit 1 is <95% of birth weight [(weight at Visit 1÷birth weight) x 100 <95%]
  • Infant is 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) and children with known head/brain disease/injury such as Microcephaly, Macrocephaly or others
  • Participation in another clinical trial
  • Known or increased risk of cow's milk allergy and/ or lactose intolerance (i.e. one of the biological parents and or siblings diagnosed with cow's milk allergy, asthma, hay fever, etc.)
  • Having a mother suffering from diabetes during pregnancy
  • Use of antibiotics at the time of screening, or during the past two weeks

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: Other
  • 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.
No Intervention: Human Milk Reference Group
Human milk
Experimental: Study Formula
a Cow's Milk Based Infant Formula Containing Both OPO and CPP for term infants (JunLeBao ZhiZhen)
Other: Study Formula
Study infant formula for term infants containing OPO and CPP
Active Comparator: Comparator Formula
Commercially available infant formula without OPO for term infants (JunLeBao LeChun)
Other: Study Formula
Study infant formula for term infants containing OPO and CPP

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
Stool characteristics
Time Frame: 1 month to 5 months
Infant Stool Form Scale to measure stool consistency, amount and color (Bekkali et al, 2009): 4-point scale as watery (A) soft (B) formed (C) or hard (D)
1 month to 5 months

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
Gastrointestinal tract discomfort
Time Frame: 1 month to 5 months
frequency of parents observed and documented GI tract discomfort
1 month to 5 months
Bone Speed Of Sound
Time Frame: at 1 month and 5 months
Ultrasound Bone Densitometer (BMD-A3)
at 1 month and 5 months
Formula intake and tolerance (24 hour dietary recall)
Time Frame: 2 months to 5 months
ml /day
2 months to 5 months
Medically-diagnosed adverse events collected throughout the study period
Time Frame: 1 month to 5 months
frequency
1 month to 5 months
Crying and sleep tracking (24 hours recall)
Time Frame: 2 months to 5 months
frequency
2 months to 5 months
Anthropometric parameters on growth
Time Frame: 1month to 5 months
Achieved body length (CM)
1month to 5 months
Anthropometric parameters on growth
Time Frame: 1month to 5 months
Achieved head circumferences (CM)
1month to 5 months
Anthropometric parameters on growth
Time Frame: 1month to 5 months
Achieved body weight (kg)
1month to 5 months
Anthropometric parameters on growth
Time Frame: 1month to 5 months
Rate of gain (%) on achieved head circumferences
1month to 5 months
Anthropometric parameters on growth
Time Frame: 1month to 5 months
Rate of gain (%) on achieved body weight
1month to 5 months
Anthropometric parameters on growth
Time Frame: 1month to 5 months
Rate of gain (%) on achieved body length
1month to 5 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.
Bunge Loders Croklaan

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Sprim Advanced Life Sciences
Junlebao Dairy Group 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: Xiaoyang Shen, MD, Xinhua Hospital, Shanghai Jiao Tong 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.
March 1, 2021

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.
October 1, 2022

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.
February 15, 2023

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).
January 30, 2021

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.
February 6, 2021

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.
February 11, 2021

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.
May 16, 2024

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.
May 13, 2024

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.
May 1, 2024

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.
  • 20-SM-09-Bunge-001

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.

Clinical Trials on Infant Development

Clinical Trials on Study Formula

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

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