Growth and Tolerance of Hypoallergenic Formulas

This study has been completed.
Sponsor:
Information provided by:
Mead Johnson Nutrition
ClinicalTrials.gov Identifier:
NCT01354366
First received: May 13, 2011
Last updated: August 28, 2013
Last verified: August 2013
  Purpose

This clinical trial will evaluate two investigational hypoallergenic infant formulas with a differing protein content to determine if they provide normal growth and are well tolerated by term infants as compared to a marketed hypoallergenic formula.


Condition Intervention
Growth of Term Infants
Other: Infant formula

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Effects on Growth and Tolerance of Hypoallergenic Formulas Fed to Term Infants

Resource links provided by NLM:


Further study details as provided by Mead Johnson Nutrition:

Primary Outcome Measures:
  • Body weight measured at each study visit [ Time Frame: 3.5 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Recall of infant formula intake at each study visit [ Time Frame: 3.5 months ] [ Designated as safety issue: No ]
  • Body Length and Head Circumference measured at each study visit [ Time Frame: 3.5 months ] [ Designated as safety issue: No ]
  • Recall of stool characteristics and tolerance at each study visit [ Time Frame: 3.5 months ] [ Designated as safety issue: No ]
  • Medically-confirmed adverse events collected throughout the study period [ Time Frame: 3.5 months ] [ Designated as safety issue: No ]
  • Parental Product Assessment Questionnaire completed at Study Visit 2 [ Time Frame: once ] [ Designated as safety issue: No ]

Enrollment: 511
Study Start Date: July 2011
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Control
Marketed hypoallergenic infant formula containing a probiotic
Other: Infant formula
Experimental 1
An investigational hypoallergenic infant formula with a different protein content, containing the same probiotic as the control
Other: Infant formula
Experimental 2
An investigational hypoallergenic infant formula with a different protein content, without a probiotic
Other: Infant formula

  Eligibility

Ages Eligible for Study:   up to 16 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Heatly, term infants

Criteria

Inclusion Criteria:

  • Singleton, 12-16 days of age at randomization
  • Term infant with birth weight of a minimum of 2500 grams
  • Solely formula fed
  • Signed Informed Consent and Protected Health Information

Exclusion Criteria:

  • History of underlying metabolic or chronic disease or immunocompromised
  • Feeding difficulties or formula intolerance
  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: NCT01354366

  Show 24 Study Locations
Sponsors and Collaborators
Mead Johnson Nutrition
Investigators
Study Director: Timothy Cooper, M.D. Mead Johnson Nutrition
  More Information

No publications provided

Responsible Party: Timothy Cooper, M.D., Mead Johnson Nutrition
ClinicalTrials.gov Identifier: NCT01354366     History of Changes
Other Study ID Numbers: 3383-1
Study First Received: May 13, 2011
Last Updated: August 28, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on September 18, 2014