CompletedNCT04749290Updated May 16, 2024

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

An interventional study of Study Formula in Infant Development, sponsored by Bunge Loders Croklaan. Completed at 2 sites in China. Open to participants aged 14 Days to 30 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-16.

Sponsored by Bunge Loders Croklaan · Not applicable, Interventional, and Other

Phase: Not applicable
Study type: Interventional
Enrollment: 180
Allocation: Randomized
Ages: 14 Days to 30 Days
Sex: All

Study summary

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).

Read the 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.

Conditions studied

Infant Development

In context

Lead sponsor

This is the only study on the registry with Bunge Loders Croklaan as lead sponsor.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 14 Days to 30 Days
Sexes eligible: All
Accepts healthy volunteers: Yes

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

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 design

Phase: Not applicable
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 180 participants (actual)

Study arms

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

Interventions

OtherStudy Formula
Study infant formula for term infants containing OPO and CPP

What researchers measure

Primary outcomes

Stool characteristics
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)
Time frame: 1 month to 5 months

Secondary outcomes

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

Study locations

2 sites

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

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on May 16, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04749290
Lead sponsor: Bunge Loders Croklaan
Collaborators: Junlebao Dairy Group Co., Ltd., Sprim Advanced Life Sciences
Responsible party: Sponsor
First posted: Feb 11, 2021
Start date: Mar 1, 2021
Primary completion: Oct 1, 2022
Completion: Feb 15, 2023
Last update: May 16, 2024

Study contacts

Xiaoyang Shen, MD

principal investigator · Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion