Clinical trial NCT04749290: Effects of an Infant Formula on Growth, Safety and Efficacy for Healthy Term Infants
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infant Development
Lead sponsor: Bunge Loders Croklaan
Sponsor class: INDUSTRY
Collaborators: name: Junlebao Dairy Group Co., Ltd.
name: Sprim Advanced Life Sciences
First posted: 2021-02-11
Enrollment: 180
Sex: ALL
Minimum age (years): 14
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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 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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Stool characteristics
timeFrame: 1 month to 5 months
Secondary outcomes:
measure: Formula intake and tolerance (24 hour dietary recall)
timeFrame: 2 months to 5 months
measure: Medically-diagnosed adverse events collected throughout the study period
timeFrame: 1 month to 5 months
measure: Crying and sleep tracking (24 hours recall)
timeFrame: 2 months to 5 months
measure: Gastrointestinal tract discomfort
timeFrame: 1 month to 5 months
measure: Anthropometric parameters on growth
timeFrame: 1month to 5 months
measure: Anthropometric parameters on growth
timeFrame: 1month to 5 months
measure: Anthropometric parameters on growth
timeFrame: 1month to 5 months
measure: Bone Speed Of Sound
timeFrame: at 1 month and 5 months
measure: Anthropometric parameters on growth
timeFrame: 1month to 5 months
measure: Anthropometric parameters on growth
timeFrame: 1month to 5 months
measure: Anthropometric parameters on growth
timeFrame: 1month to 5 months
Other outcomes:
Locations:
city: Jinhua
country: China
facility: JiangNan Street Community Health Service Center, WuCheng District
city: Jinhua
country: China
facility: QiuBin Street Community Health Service Center, WuCheng District
Study officials:
affiliation: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
name: Xiaoyang Shen, MD
role: PRINCIPAL_INVESTIGATOR
References: