Probiotic Formula and Infant Growth

Nestlé

Status

Completed

Conditions

Healthy

Treatments

Other: Control infant formula

Other: Test infant formula

Study type

Interventional

Funder types

Industry

Identifiers

NCT01476397

10.01.US.INF

Details and patient eligibility

About

This is a growth study of full-term, formula-fed infants randomized to receive a partially hydrolyzed whey protein formula with and without probiotics for the first four months of life. It is hypothesized that there will be no difference in growth between the two groups.

Sex

All

Ages

11 to 17 days old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy newborn infant
Full-term
Birth weight > 2500 and < 4500 g
14±3 days of age on enrollment
Exclusively formula-fed, singleton birth
Having obtained his/her legal representative's informed consent

Exclusion criteria

Known or suspected cow-milk allergy
Congenital illness or malformation that may affect infant feeding and/or growth
Significant prenatal and/or postnatal disease
Any readmission to hospital prior to enrollment
Receiving prescription medication or frequent use of over the counter medications except vitamin and mineral supplements
Has received intravenous antibiotic therapy or oral probiotic in the last 7 days
Currently participating in another clinical study
Cannot be expected to comply with treatment