Probiotic Formula and Infant Growth

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Other: Test infant formula; Other: Control infant formula

• Registration Number: NCT01476397
• Lead Sponsor: Société des Produits Nestlé (SPN)

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-11-14
• Study First Submitted QC: 2011-11-17
• Study First Posted: 2011-11-22
• Study Start: 2011-12
• Primary Completion: 2013-06
• Study Completion: 2013-10
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-03
• Last Update Posted: 2014-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
test infant formula	Test infant formula	partially hydrolyzed whey infant formula with probiotic
control infant formula	Control infant formula	partially hydrolyzed whey infant formula

Primary Outcome Measures

Name	Time	Method
growth	4 months	weight gain assessed monthly

Secondary Outcome Measures

Name	Time	Method
other growth	4 months	Length, head circumference will be measured at monthly visits
adverse events	4 months	all adverse events will be documented throughout the study
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

Trial Locations

Locations (8)

North Scottsdale Pediatric Associates; 🇺🇸 Scottsdale, Arizona, United States

Kentucky Pediatric Adult Research; 🇺🇸 Bardstown, Kentucky, United States

PMG Research of Winston-Salem; 🇺🇸 Winston-Salem, North Carolina, United States

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States

PMG Research of Bristol; 🇺🇸 Bristol, Tennessee, United States

Advanced Pediatrics; 🇺🇸 Vienna, Virginia, United States

Pediatric Healthcare of Northwest Houston; 🇺🇸 Tomball, Texas, United States

Pediatrics & Adolescent Medicine; 🇺🇸 Marietta, Georgia, United States