Feeding Infant Formula With Added Probiotics and Whey Protein Concentrate

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

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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