Status:
COMPLETED
Double Blind Controlled Trial of an Extensively Hydrolyzed Formula With a Probiotic vs. an Extensively Hydrolyzed Formula Without a Probiotic
Lead Sponsor:
Mead Johnson Nutrition
Conditions:
Allergy
Eligibility:
Up to 14 years
Phase:
NA
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.
Eligibility Criteria
Inclusion
- ≤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
- 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
Key Trial Info
Start Date :
January 1 2003
Trial Type :
INTERVENTIONAL
End Date :
November 1 2004
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01181297
Start Date
January 1 2003
End Date
November 1 2004
Last Update
August 13 2010
Active Locations (2)
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1
Dept. of Paediatrics, Azienda Ospedaliera di Padova
Padua, Veneto, Italy, 35128
2
Wilhelmina Children's Hospital
Utrecht, Utrecht, Netherlands, 3508