Probiotic Formula and Infant Growth

ASSESSMENT OF GROWTH OF INFANTS FED FORMULA WITH PROBIOTICS

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01476397

Enrollment

Unknown

Registered

2011-11-22

Start date

2011-12-31

Completion date

2013-10-31

Last updated

2014-11-04

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

Conditions

Healthy

Keywords

full-term, formula-fed infants

Brief summary

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.

Interventions

OTHERControl infant formula

partially hydrolyzed whey infant formula consumed ad libitum throughout study

OTHERTest infant formula

partially hydrolyzed whey formula with probiotic

Eligibility

Sex/Gender

ALL

Age

11 Days to 17 Days

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
growth	4 months	weight gain assessed monthly

Secondary

Measure	Time frame	Description
adverse events	4 months	all adverse events will be documented throughout the study
other growth	4 months	Length, head circumference will be measured at monthly visits
stool characteristics	throughout study	stool frequency, color, consistency
spit-up	throughout study	frequency of spit-up as reported by caregivers
vomit	throughout study	frequency of vomitting as reported by caregivers

Countries

United States

Outcome results

None listed

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