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

NCT04749290 | Completed DMC

• 1 other identifier: 20-SM-09-Bunge-001
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 2

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).

Conditions

Infant Development

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Formula intake and tolerance (24 hour dietary recall)

  2 months to 5 months

• Medically-diagnosed adverse events collected throughout the study period

  1 month to 5 months

• Crying and sleep tracking (24 hours recall)

  2 months to 5 months

• Gastrointestinal tract discomfort

  1 month to 5 months

• Anthropometric parameters on growth

  1month to 5 months

Study Arms (3)

Study Formula

EXPERIMENTAL

a Cow's Milk Based Infant Formula Containing Both OPO and CPP for term infants (JunLeBao ZhiZhen)

Other: Study Formula

Comparator Formula

ACTIVE COMPARATOR

Commercially available infant formula without OPO for term infants (JunLeBao LeChun)

Other: Study Formula

Human Milk Reference Group

NO INTERVENTION

Human milk

Interventions

Study Formula OTHER

Study infant formula for term infants containing OPO and CPP

Comparator Formula; Study Formula

Eligibility Criteria

• Age: 14 Days - 30 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bunge Loders Croklaan: lead
• Junlebao Dairy Group Co., Ltd.: collaborator
• Sprim Advanced Life Sciences: collaborator

Study Sites (2)

JiangNan Street Community Health Service Center, WuCheng District

Jinhua, China

Location

QiuBin Street Community Health Service Center, WuCheng District

Jinhua, China

Location

Related Publications (1)

• Sheng XY, Mi W, Yuan QB, Liu BY, Carnielli V, Ning YB, Einerhand AWC. An A2 beta-casein infant formula with high sn-2 palmitate and casein phosphopeptides supports adequate growth, improved stool consistency, and bone strength in healthy, term Chinese infants: a randomized, double-blind, controlled clinical trial. Front Nutr. 2024 Aug 14;11:1442584. doi: 10.3389/fnut.2024.1442584. eCollection 2024.

  PMID: 39206307 DERIVED

Study Officials

• Xiaoyang Shen, MD

  Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2021
• First Posted: February 11, 2021
• Study Start: March 1, 2021
• Primary Completion: October 1, 2022
• Study Completion: February 15, 2023
• Last Updated: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)