Status:
COMPLETED
Effects of an Infant Formula on Growth, Safety and Efficacy for Healthy Term Infants
Lead Sponsor:
Bunge Loders Croklaan
Collaborating Sponsors:
Junlebao Dairy Group Co., Ltd.
Sprim Advanced Life Sciences
Conditions:
Infant Development
Eligibility:
All Genders
14-30 years
Phase:
NA
Brief 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 ...
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 ter...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 15 2023
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT04749290
Start Date
March 1 2021
End Date
February 15 2023
Last Update
May 16 2024
Active Locations (2)
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1
JiangNan Street Community Health Service Center, WuCheng District
Jinhua, China
2
QiuBin Street Community Health Service Center, WuCheng District
Jinhua, China