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Growth and Tolerance of Hypoallergenic Formulas

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ClinicalTrials.gov Identifier: NCT01354366
Recruitment Status : Completed
First Posted : May 16, 2011
Last Update Posted : August 29, 2013
Sponsor:
Information provided by:
Mead Johnson Nutrition

Brief Summary:
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 or disease Intervention/treatment
Growth of Term Infants Other: Infant formula

Study Type : Observational
Actual Enrollment : 511 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Effects on Growth and Tolerance of Hypoallergenic Formulas Fed to Term Infants
Study Start Date : July 2011
Primary Completion Date : December 2012
Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
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



Primary Outcome Measures :
  1. Body weight measured at each study visit [ Time Frame: 3.5 months ]

Secondary Outcome Measures :
  1. Recall of infant formula intake at each study visit [ Time Frame: 3.5 months ]
  2. Body Length and Head Circumference measured at each study visit [ Time Frame: 3.5 months ]
  3. Recall of stool characteristics and tolerance at each study visit [ Time Frame: 3.5 months ]
  4. Medically-confirmed adverse events collected throughout the study period [ Time Frame: 3.5 months ]
  5. Parental Product Assessment Questionnaire completed at Study Visit 2 [ Time Frame: once ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 16 Days   (Child)
Sexes Eligible for Study:   All
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

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 ClinicalTrials.gov identifier (NCT number): NCT01354366


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

Responsible Party: Timothy Cooper, M.D., Mead Johnson Nutrition
ClinicalTrials.gov Identifier: NCT01354366     History of Changes
Other Study ID Numbers: 3383-1
First Posted: May 16, 2011    Key Record Dates
Last Update Posted: August 29, 2013
Last Verified: August 2013