Probiotic Formula and Infant Growth

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Nestlé
ClinicalTrials.gov Identifier:
NCT01476397
First received: November 14, 2011
Last updated: October 30, 2013
Last verified: October 2013
  Purpose

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 Intervention
Healthy
Other: Control infant formula
Other: Test infant formula

Study Type: Interventional
Official Title: ASSESSMENT OF GROWTH OF INFANTS FED FORMULA WITH PROBIOTICS

Resource links provided by NLM:


Further study details as provided by Nestlé:

Primary Outcome Measures:
  • growth [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    weight gain assessed monthly


Secondary Outcome Measures:
  • other growth [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Length, head circumference will be measured at monthly visits

  • adverse events [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
    all adverse events will be documented throughout the study

  • stool characteristics [ Time Frame: throughout study ] [ Designated as safety issue: No ]
    stool frequency, color, consistency

  • spit-up [ Time Frame: throughout study ] [ Designated as safety issue: No ]
    frequency of spit-up as reported by caregivers

  • vomit [ Time Frame: throughout study ] [ Designated as safety issue: No ]
    frequency of vomitting as reported by caregivers


Study Start Date: December 2011
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   up to 17 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01476397

Locations
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
Nestlé
  More Information

No publications provided

Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT01476397     History of Changes
Other Study ID Numbers: 10.01.US.INF
Study First Received: November 14, 2011
Last Updated: October 30, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Nestlé:
full-term
formula-fed infants

ClinicalTrials.gov processed this record on August 28, 2014