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Evaluation of Tolerance, Efficacy and Safety of an Hydrolyzed Formula in Infants With IgE/Non-IgE Mediated CMA.
Sponsor: United Pharmaceuticals
Summary
The aim of this interventional study is to assess the hypoallergenicity of a new formula in infants having a cow milk allergy (CMA), whatever the type of CMA, meaning in both IgE-mediated and non-IgE-mediated CMA patients. This will be tested through a double-blind placebo controlled food challenge (DBPCFC) taking place over 2 or 3 separate days, in hospital. If the child tolerates the tested formula during the DBPCFC, he will be fed with the test formula during the second study phase. There will be monthly visit and parents will be asked to fill in diaries.
Official title: Cow's Milk Allergy (CMA): Evaluation of Tolerance, Efficacy and Safety of a Thickened Extensively Hydrolyzed Formula in Infants With IgE and Non-IgE Mediated CMA
Key Details
Gender
All
Age Range
1 Month - 24 Months
Study Type
INTERVENTIONAL
Enrollment
70
Start Date
2024-08-14
Completion Date
2026-06
Last Updated
2025-01-07
Healthy Volunteers
No
Conditions
Interventions
Test Formula
Infants will receive an extensively hydrolyzed formula during the double-blind placebo-controlled food challenge (DBPCFC) and will continue on this formula during the open-label feeding phase if they tolerate it.
Placebo Formula
Infants will receive a placebo formula during the DBPCFC to compare against the test formula.
Locations (2)
Private practice Elena BRADATAN
Namur, Begium, Belgium
University Hospital - Umberto I Sapienza
Roma, Italy