Status:

COMPLETED

Tolerability and Safety of An Infant Formula

Lead Sponsor:

Perrigo Nutritionals

Conditions:

Milk Hypersensitivity

Eligibility:

All Genders

1-12 years

Phase:

NA

Brief Summary

The purpose of this study is to evaluate an extensively hydrolyzed formula in infants with cow's milk allergy.

Eligibility Criteria

Inclusion

  • clinically diagnosed CMA
  • \</= 12 weeks at time of study entry
  • full-term infant
  • must be willing to use provided formula as sole source of nutrition
  • other than CMA, infant must be otherwise healthy

Exclusion

  • underlying or confounding gastrointestinal abnormalities
  • infants born from an addictive situation, HIV positive
  • if parent/guardian is considered likely to be non-compliant with the protocol requirements

Key Trial Info

Start Date :

August 1 2007

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

January 1 2009

Estimated Enrollment :

108 Patients enrolled

Trial Details

Trial ID

NCT00938483

Start Date

August 1 2007

End Date

January 1 2009

Last Update

July 15 2009

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