Feeding Infant Formula With Added Probiotics and Whey Protein Concentrate

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01755481

Enrollment

800

Registered

2012-12-24

Start date

2012-12-31

Completion date

2017-08-31

Last updated

2018-01-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Focus on Healthy Infants

Brief summary

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

Interventions

OTHERProbiotic

OTHERWhey protein concentrate

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

No minimum to 2 Weeks

Healthy volunteers

Yes

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%

Design outcomes

Primary

Measure	Time frame
Infections episodes (gastrointestinal and upper and lower respiratory infections)	4 yrs

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026