Probiotic Formula and Infant Growth

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01476397
Recruitment Status : Completed
First Posted : November 22, 2011
Last Update Posted : November 4, 2014
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Healthy Other: Control infant formula Other: Test infant formula Not Applicable

Study Type : Interventional  (Clinical Trial)
Study Start Date : December 2011
Actual Primary Completion Date : June 2013
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: control infant formula
partially hydrolyzed whey infant formula
Other: Control infant formula
partially hydrolyzed whey infant formula consumed ad libitum throughout study
Experimental: test infant formula
partially hydrolyzed whey infant formula with probiotic
Other: Test infant formula
partially hydrolyzed whey formula with probiotic

Primary Outcome Measures :
  1. growth [ Time Frame: 4 months ]
    weight gain assessed monthly

Secondary Outcome Measures :
  1. other growth [ Time Frame: 4 months ]
    Length, head circumference will be measured at monthly visits

  2. adverse events [ Time Frame: 4 months ]
    all adverse events will be documented throughout the study

  3. stool characteristics [ Time Frame: throughout study ]
    stool frequency, color, consistency

  4. spit-up [ Time Frame: throughout study ]
    frequency of spit-up as reported by caregivers

  5. vomit [ Time Frame: throughout study ]
    frequency of vomitting as reported by caregivers

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 17 Days   (Child)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01476397

United States, Arizona
North Scottsdale Pediatric Associates
Scottsdale, Arizona, United States, 85258
United States, Georgia
Pediatrics & Adolescent Medicine
Marietta, Georgia, United States, 30189
United States, Kentucky
Kentucky Pediatric Adult Research
Bardstown, Kentucky, United States, 40004
United States, North Carolina
PMG Research of Winston-Salem
Winston-Salem, North Carolina, United States, 27103
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Tennessee
PMG Research of Bristol
Bristol, Tennessee, United States, 37620
United States, Texas
Pediatric Healthcare of Northwest Houston
Tomball, Texas, United States, 77375
United States, Virginia
Advanced Pediatrics
Vienna, Virginia, United States, 22180
Sponsors and Collaborators

Responsible Party: Nestlé Identifier: NCT01476397     History of Changes
Other Study ID Numbers: 10.01.US.INF
First Posted: November 22, 2011    Key Record Dates
Last Update Posted: November 4, 2014
Last Verified: November 2014

Keywords provided by Nestlé:
formula-fed infants