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

Infant Development Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04749290
• Other study ID #: 20-SM-09-Bunge-001
• Status: Completed
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: February 15, 2023

Study information

• Verified date: May 2024
• Source: Bunge Loders Croklaan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: February 15, 2023
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Days to 30 Days

Eligibility

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

Related Conditions & MeSH terms

• Infant Development

Intervention

Other:
• Study Formula
Study infant formula for term infants containing OPO and CPP

Locations

Country	Name	City	State
China	JiangNan Street Community Health Service Center, WuCheng District	Jinhua
China	QiuBin Street Community Health Service Center, WuCheng District	Jinhua

Sponsors (3)

Lead Sponsor	Collaborator
Bunge Loders Croklaan	Junlebao Dairy Group Co., Ltd., Sprim Advanced Life Sciences

Country where clinical trial is conducted

China, 

Outcome

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