Status:
COMPLETED
Evaluation of the Hypoallergenicity of an Extensively Hydrolyzed Formula
Lead Sponsor:
United Pharmaceuticals
Conditions:
Cow Milk Allergy
Eligibility:
All Genders
1-36 years
Phase:
PHASE3
Brief Summary
The aim of this study is to assess the hypoallergenicity of a new thickened extensively hydrolyzed formula, in infants with confirmed cow's milk protein allergy assessed through a double blind placebo...
Eligibility Criteria
Inclusion
- Main Inclusion Criteria:
- Infants:
- with cow's milk allergy confirmed by a double-blind food challenge performed in the last 2 months,
- successfully fed an eviction diet for at least 2 weeks
- Main Non-inclusion Criteria:
- Infants:
- fed with an extensively hydrolyzed formula with no improvement of the symptoms,
- who refused to drink an extensively hydrolyzed formula anytime prior to inclusion,
- fed a vegetable based formula
- fed an amino acid based formula or who should be fed with an amino acid based formula according to recommendations
- who had an anaphylactic reaction in the past
Exclusion
Key Trial Info
Start Date :
April 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 29 2017
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT02711163
Start Date
April 1 2016
End Date
November 29 2017
Last Update
May 15 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Umberto I university hospital
Roma, Italy