Specific Oral Tolerance Induction to Cow's Milk Allergy
|ClinicalTrials.gov Identifier: NCT01199484|
Recruitment Status : Completed
First Posted : September 13, 2010
Last Update Posted : September 13, 2010
Background: Limited published evidence shows specific oral tolerance induction (SOTI) to be a potential intervention option for cow's milk proteins (CMPs) allergy. Our hypothesis is that SOTI should be started early in order to improve its efficacy and prevent CMPs sensitization from evolving towards persistent allergy. The aim of this study was to evaluate the safety and efficacy of SOTI in 2-year-old children with cow's milk allergy, as a treatment alternative to elimination diet.
Methods: A total of 60 children between 24-36 months of age with IgE-mediated allergy to CMPs were included in this multicenter study and were randomly divided into two different groups. Thirty children (group A: treatment group) began SOTI immediately, whereas the remaining 30 (group B: control group) were kept on a milk-free diet and followed-up on for one year.
|Condition or disease||Intervention/treatment||Phase|
|Food Hypersensitivity||Other: Cow's milk||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Specific Oral Tolerance Induction as an Useful Treatment in Two-year-old Children With Cow's Milk Allergy.|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01199484
|Allergy Unit. University General Hospital|
|Valencia, Spain, 46014|