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

NCT04749290 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2024-05-16

No results posted yet for this study

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

Interventions

OTHER

Study Formula

Study infant formula for term infants containing OPO and CPP

Sponsors & Collaborators

  • Junlebao Dairy Group Co., Ltd.

    collaborator INDUSTRY

  • Sprim Advanced Life Sciences

    collaborator OTHER

  • Bunge Loders Croklaan

    lead INDUSTRY

Principal Investigators

  • Xiaoyang Shen, MD · Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
14 Days
Max Age
30 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-03-01
Primary Completion
2022-10-01
Completion
2023-02-15

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04749290 on ClinicalTrials.gov