Status:
UNKNOWN
Efficacy of the "Milk Ladder" Intervention in the Development of Tolerance and the Recognition of B Cell Epitopes in Babies Who Are Allergic to Cow's Milk Proteins
Lead Sponsor:
Hospital San Carlos, Madrid
Conditions:
IgE-mediated Milk Allergy
Eligibility:
All Genders
1-12 years
Phase:
NA
Brief Summary
Food allergies have become a relevant health problem in westernized societies, particularly, with children. Cow's milk (CM), along with hen's eggs, are the most common foods eliciting allergic reactio...
Eligibility Criteria
Inclusion
- Babies of both sexes.
- Age \< 12 months.
- Clinical history of immediate reaction (\<2 hours) after the intake of baby's formula and/or foods containing cow's milk.
- Sensitization to cow's milk proteins demonstrated by:
- sIgE to cow's milk, alpha-Lactoabumin, beta-Lactoglobulin and/or Casein \>0.1KU/l (ImmunoCAP®, ThemoFisher) and/or
- Skin prick test to cow's milk, alpha-Lactoabumin, beta-Lactoglobulin and/or Casein ≥3mm
- If the reaction to milk occurred over 3 months before the recruitment, it will be mandatory to confirm reactivity to milk with an oral food test.
- Parents / legal representatives of the participant voluntary accept to participate.
Exclusion
- Delayed reactions (\> 2 h) after milk intake.
- Contact urticaria to milk if ingestion is well tolerated.
- Previous participation in oral tolerance induction/desensitization protocols.
- Treatment with any medication that might interfere the evaluation of the primary outcome or any study procedure.
- Any disease or condition which presents a contraindication to perform an oral challenge, either open or double-blind or any other study procedure.
- Social circumstances that might interfere with protocol adherence.
- Egg and/or wheat allergy (this exclusion criterion shall be verified before the beginning of the intervention).
Key Trial Info
Start Date :
June 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 30 2021
Estimated Enrollment :
114 Patients enrolled
Trial Details
Trial ID
NCT03466931
Start Date
June 1 2018
End Date
August 30 2021
Last Update
June 26 2020
Active Locations (1)
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1
Hospital Clinico San Carlos
Madrid, Spain, 28040