Feeding Infant Formula With Added Probiotics and Whey Protein Concentrate

NCT ID: NCT01755481

Last Updated: 2018-01-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2017-08-31

Brief Summary

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To evaluate the effects of feeding an infant formula containing L. paracasei ssp. paracasei strain F19 or Whey Protein Concentrate.

Detailed Description

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Conditions

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Focus on Healthy Infants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Probiotics F19

F19 in an infant formula

Group Type EXPERIMENTAL

Probiotic

Intervention Type OTHER

Whey protein concentrate

Whey protein concentrate in an infant formula

Group Type EXPERIMENTAL

Whey protein concentrate

Intervention Type OTHER

Interventions

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Probiotic

Intervention Type OTHER

Whey protein concentrate

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

healthy infants of mothers who could not or voluntarily resigned completely from breast-feeding at infant age 14 plus/minus 3 days


healthy infants exclusively breast-fed from birth and mothers intending to breastfeed \>80% until at least 5th month of age (meaning through the 4th month of age).


delivered between 37 and 42 weeks of gestation birth weight \>2500 g and \<4000 g parent or the subject's legal representative speak and understand Chinese

Exclusion Criteria

fully or partially breast-fed infants infants breast-fed \>20%


infants fed \>20% infant formula


malformations, handicaps or congenital diseases that could affect normal feeding or growth treatment with antibiotics
Maximum Eligible Age

2 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Arla Foods

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yongmei Peng, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital, Fudan University, Shanghai, China

Locations

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Department of Child Health Care, Children's Hospital, Fudan University

Shanghai, , China

Site Status

Countries

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China

Other Identifiers

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327727-2

Identifier Type: -

Identifier Source: org_study_id

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