Status:
COMPLETED
Probiotic Formula and Infant Growth
Lead Sponsor:
Société des Produits Nestlé (SPN)
Conditions:
Healthy
Eligibility:
All Genders
11-17 years
Phase:
NA
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 hypothes...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
End Date :
October 1 2013
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01476397
Start Date
December 1 2011
End Date
October 1 2013
Last Update
November 4 2014
Active Locations (8)
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1
North Scottsdale Pediatric Associates
Scottsdale, Arizona, United States, 85258
2
Pediatrics & Adolescent Medicine
Marietta, Georgia, United States, 30189
3
Kentucky Pediatric Adult Research
Bardstown, Kentucky, United States, 40004
4
PMG Research of Winston-Salem
Winston-Salem, North Carolina, United States, 27103