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Specific Oral Tolerance Induction to Cow's Milk Allergy

NCT01199484 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL

Last updated 2010-09-13

No results posted yet for this study

Summary

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.

Conditions

  • Food Hypersensitivity

Interventions

OTHER

Cow's milk

Sponsors & Collaborators

  • General University Hospital of Valencia

    lead OTHER

Eligibility

Min Age
24 Months
Max Age
36 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01199484 on ClinicalTrials.gov