Back to resultsSpecific Oral Tolerance Induction to Cow's Milk Allergy
Primary Purpose
Food Hypersensitivity
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Cow's milk
Sponsored by
About this trial
This is an interventional trial for Food Hypersensitivity focused on measuring Cow's milk allergy, food allergy, oral desensitization, randomized trial, specific oral tolerance induction.
Eligibility Criteria
Inclusion Criteria:
- -Infants between 24-36 months of age.
-IgE-mediated allergy to CMPs meeting all the following diagnostic criteria:
- Immediate-type clinical manifestations, skin (urticaria, angioedema and/or erythema), digestive (acute vomiting and/or diarrhea) or respiratory (bronchospasm and/or rhinitis) involvement in the first two hours after cow's milk ingestion.
- Skin test readings ≥ 3 mm and specific IgE titers > 0.35 kU/l for whole cow's milk or someone of isolated CMPs (casein, alpha-lactalbumin, beta-lactoglobulin )
-Persistence of CMP allergy in the four weeks prior to tolerance induction, based on the following criteria:
- Skin (prick) test readings ≥3 mm and specific IgE titers (CAP-FEIA) >0.35 kU/l for whole cow's milk or someone of isolated CMPs (casein, alpha-lactalbumin, beta-lactoglobulin )
- Double-blind placebo-controlled challenge (DBPCFC) positive to cow's milk.
- -Written informed consent from the parents.
Exclusion Criteria:
- -Clinical manifestations of anaphylactic shock after the ingestion of cow's milk.
- -Non-IgE-mediated or non-immunological adverse reactions to cow's milk.
- -Malignant or immunopathological diseases and/or severe primary or secondary immune deficiencies.
- -Patients receiving immunosuppressor therapy.
- -Patients receiving beta-blockers (including topical formulations).
- -Associated diseases contraindicating the use of adrenalin: cardiovascular disease or severe hypertension
Sites / Locations
- Allergy Unit. University General Hospital
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT01199484
First Posted
September 9, 2010
Last Updated
September 10, 2010
Sponsor
General University Hospital of Valencia
1. Study Identification
Unique Protocol Identification Number
NCT01199484
Brief Title
Specific Oral Tolerance Induction to Cow's Milk Allergy
Official Title
Specific Oral Tolerance Induction as an Useful Treatment in Two-year-old Children With Cow's Milk Allergy.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
General University Hospital of Valencia
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Food Hypersensitivity
Keywords
Cow's milk allergy, food allergy, oral desensitization, randomized trial, specific oral tolerance induction.
7. Study Design
Study Phase
Not Applicable
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
Cow's milk
10. Eligibility
Sex
All
Minimum Age & Unit of Time
24 Months
Maximum Age & Unit of Time
36 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
-Infants between 24-36 months of age.
-IgE-mediated allergy to CMPs meeting all the following diagnostic criteria:
Immediate-type clinical manifestations, skin (urticaria, angioedema and/or erythema), digestive (acute vomiting and/or diarrhea) or respiratory (bronchospasm and/or rhinitis) involvement in the first two hours after cow's milk ingestion.
Skin test readings ≥ 3 mm and specific IgE titers > 0.35 kU/l for whole cow's milk or someone of isolated CMPs (casein, alpha-lactalbumin, beta-lactoglobulin )
-Persistence of CMP allergy in the four weeks prior to tolerance induction, based on the following criteria:
Skin (prick) test readings ≥3 mm and specific IgE titers (CAP-FEIA) >0.35 kU/l for whole cow's milk or someone of isolated CMPs (casein, alpha-lactalbumin, beta-lactoglobulin )
Double-blind placebo-controlled challenge (DBPCFC) positive to cow's milk.
-Written informed consent from the parents.
Exclusion Criteria:
-Clinical manifestations of anaphylactic shock after the ingestion of cow's milk.
-Non-IgE-mediated or non-immunological adverse reactions to cow's milk.
-Malignant or immunopathological diseases and/or severe primary or secondary immune deficiencies.
-Patients receiving immunosuppressor therapy.
-Patients receiving beta-blockers (including topical formulations).
-Associated diseases contraindicating the use of adrenalin: cardiovascular disease or severe hypertension
Facility Information:
Facility Name
Allergy Unit. University General Hospital
City
Valencia
ZIP/Postal Code
46014
Country
Spain
12. IPD Sharing Statement
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Specific Oral Tolerance Induction to Cow's Milk Allergy
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