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

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: Recruiting
• Conditions: Infant Development
• Intervention / Treatment: Other: Study Formula

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: Interventional
• Enrollment (Anticipated): 180
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christin Zhang; Phone Number: 86 021-63735886; Email: christin.zhang@sprimmedical.com

Study Locations

• China
  • Jinhua, China
    • Recruiting
    • JiangNan Street Community Health Service Center, WuCheng District
    • Contact: Shirley Zhu
  • Jinhua, China
    • Recruiting
    • QiuBin Street Community Health Service Center, WuCheng District
    • Contact: Christin Zhang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 weeks to 1 month (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

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

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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
NO_INTERVENTION: Human Milk Reference Group; Human milk

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anthropometric parameters	Achieved body length (cm) and rate of gain	1month to 5 months
Anthropometric parameters	Achieved body weight (kg) and rate of gain	1month to 5 months
Anthropometric parameters	Achieved head circumferences (cm) and rate of gain	1month to 5 months
Stool characteristics	Infant Stool Form Scale to measure stool consistency (Bekkali et al, 2009): 4-point scale as watery (A) soft (B) formed (C) or hard (D)	1 month to 5 months
Stool characteristics	Infant Stool Form Scale to measure stool amount (Bekkali et al, 2009): 4-pont scale as smear (1), up to 25% (2), 25-50% (3) or >50% (4)	1 month to 5 months
Stool characteristics	Infant Stool Form Scale to measure stool color (Bellali et al, 2009): 6 categories as yellow (I), orange (II), green (III), brown (IV), meconium (V) or clay-colored (VI)	1 month to 5 months
Gastrointestinal tract discomfort	frequency of parents observed and documented GI tract discomfort	1 month to 5 months
Bone Speed Of Sound	Ultrasound Bone Densitometer (BMD-A3)	at 1 month and 5 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Formula intake and tolerance (24 hour dietary recall)	ml /day	2 months to 5 months
Medically-diagnosed adverse events collected throughout the study period	frequency	1 month to 5 months
Crying and sleep tracking (24 hours recall)	frequency	2 months to 5 months
Bone Mineral Content/Density	DEXA	at 5 months

Collaborators and Investigators

• Sponsor: Bunge Loders Croklaan
• Collaborators: Sprim Advanced Life Sciences; Shijiazhuang Junlebao Dairy Co., Ltd.
• Investigators: Principal Investigator: Xiaoyang Shen, MD, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2021
• Primary Completion (ANTICIPATED): August 1, 2022
• Study Completion (ANTICIPATED): September 1, 2022

Study Registration Dates

• First Submitted: January 30, 2021
• First Submitted That Met QC Criteria: February 6, 2021
• First Posted (ACTUAL): February 11, 2021

Study Record Updates

• Last Update Posted (ACTUAL): March 2, 2022
• Last Update Submitted That Met QC Criteria: February 28, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Other Study ID 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