Trials / Completed
CompletedNCT01199484
Specific Oral Tolerance Induction to Cow's Milk Allergy
Specific Oral Tolerance Induction as an Useful Treatment in Two-year-old Children With Cow's Milk Allergy.
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- —
- Sponsor
- General University Hospital of Valencia · Academic / Other
- Sex
- All
- Age
- 24 Months – 36 Months
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Cow's milk |
Timeline
- First posted
- 2010-09-13
- Last updated
- 2010-09-13
Locations
1 site across 1 country: Spain
Source: ClinicalTrials.gov record NCT01199484. Inclusion in this directory is not an endorsement.