Probiotic Formula and Infant Growth

Status:	Recruiting
Conditions:	Healthy Studies
Therapuetic Areas:	Other
Healthy:	No
Age Range:	Any
Updated:	10/19/2013
Start Date:	November 2011

ASSESSMENT OF GROWTH OF INFANTS FED FORMULA WITH PROBIOTICS

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.

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

We found this trial at

sites

PMG Research of Bristol, LLC

Bristol, Tennessee 37620

from

Bristol, TN