Probiotic Formula and Infant Growth

Completed · Not applicable

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT01476397

Run by

Société des Produits Nestlé (SPN)

Starts

2011-12-01

Expected to finish

2013-10-01

Last updated by the study team

2014-11-04

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• North Scottsdale Pediatric Associates — Scottsdale, Arizona, United States
• Pediatrics & Adolescent Medicine — Marietta, Georgia, 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
• Pediatric Healthcare of Northwest Houston — Tomball, Texas, United States
• Advanced Pediatrics — Vienna, Virginia, United States

Full record on ClinicalTrials.gov

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