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Growth and Tolerance of Hypoallergenic Formulas

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
Mead Johnson Nutrition
ClinicalTrials.gov Identifier:
NCT01354366
First received: May 13, 2011
Last updated: August 22, 2012
Last verified: August 2012
History of Changes
  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:

U.S. FDA Resources

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 ]

Estimated Enrollment: 405
Study Start Date: July 2011
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: November 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
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 22, 2012
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on May 23, 2013