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Clinical Trials/NCT01584245
NCT01584245
Terminated
Not Applicable

Evaluation of the Efficacy of an Amino Acid Based Formula in Infants

Mead Johnson Nutrition5 sites in 1 country32 target enrollmentFebruary 2012
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ConditionsCow's Milk Allergy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cow's Milk Allergy
Sponsor
Mead Johnson Nutrition
Enrollment
32
Locations
5
Primary Endpoint
Weight gain
Status
Terminated
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

This clinical trial will evaluate the efficacy of an amino acid formula in infants with allergic manifestations.

Registry
clinicaltrials.gov
Start Date
February 2012
End Date
July 2014
Last Updated
11 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Mead Johnson Nutrition
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •Weight loss within the past 4 weeks
  • •Infants 1-12 months of age feeding a hypoallergenic formula for at least 2 weeks
  • •Birth weight greater than or equal to 1500 grams
  • •Solely enteral fed
  • •Infants with at least one persistent allergy symptom
  • •No change in medication within 10 days of beginning the study and no plans for change during the first 10 days of the study
  • •Signed informed consent

Exclusion Criteria

  • •History of underlying condition which, in the Investigator's opinion, could interfere with normal growth, development, or assessment of the participant
  • •Metabolic disease requiring special attention

Outcomes

Primary Outcomes

Weight gain

Time Frame: 12 weeks

Secondary Outcomes

  • Allergic manifestations(12 weeks)

Study Sites (5)

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