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Feeding Infant Formula With Added Probiotics and Whey Protein Concentrate

A

Arla Foods

Status

Completed

Conditions

Focus on Healthy Infants

Treatments

Other: Probiotic
Other: Whey protein concentrate

Study type

Interventional

Funder types

Industry

Identifiers

NCT01755481
327727-2

Details and patient eligibility

About

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

Enrollment

800 patients

Sex

All

Ages

Under 2 weeks old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria (formula-fed group):

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

Inclusion criteria (breast-fed group):

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).

Inclusion criteria (all infants):

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 (formula-fed group):

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

Exclusion criteria (breast-fed group):

infants fed >20% infant formula

Exclusion criteria (all infants):

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

800 participants in 2 patient groups

Probiotics F19
Experimental group
Description:
F19 in an infant formula
Treatment:
Other: Probiotic
Whey protein concentrate
Experimental group
Description:
Whey protein concentrate in an infant formula
Treatment:
Other: Whey protein concentrate

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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