NCT01181297
Completed
Not Applicable
Double Blind Controlled Trial of an Extensively Hydrolyzed Formula With a Probiotic vs. an Extensively Hydrolyzed Formula Without a Probiotic
Mead Johnson Nutrition2 sites in 2 countriesJanuary 2003
ConditionsAllergy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Allergy
- Sponsor
- Mead Johnson Nutrition
- Locations
- 2
- Status
- Completed
- Last Updated
- 15 years ago
Overview
Brief Summary
The purpose of this study is to confirm the hypoallergenicity of an extensively hydrolyzed formula with an added probiotic in children with documented milk allergy.
Investigators
Eligibility Criteria
Inclusion Criteria
- •≤14 years of age
- •Essentially asymptomatic for a minimum of 7 days pre-challenge.
- •Successful previous consumption of Extensively Hydrolyzed Formula within 1 week of study enrollment
- •Medically documented allergy to cow's milk
Exclusion Criteria
- •Presence of underlying systemic disease or other illness
- •Used Beta-blockers within 12-24 hours of challenges
- •Use of short-acting antihistamines within 3 days
- •Use of medium-acting antihistamines within 7 days
- •Use of long-acting antihistamines within 6 weeks
- •Use of oral steroid medication within 3 weeks
Outcomes
Primary Outcomes
Not specified
Study Sites (2)
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