Study of Milk Allergy and Tolerance in Children
| Status: | Completed |
|---|---|
| Conditions: | Food Studies, Neurology |
| Therapuetic Areas: | Neurology, Pharmacology / Toxicology |
| Healthy: | No |
| Age Range: | 4 - 10 |
| Updated: | 4/21/2016 |
| Start Date: | August 2008 |
| End Date: | November 2014 |
Dietary Intervention in Milk Allergy and Tolerance Development
The purpose of this study is to determine if children who are allergic to milk can increase
tolerance through frequent dose-escalation every 6 months versus 12 months leading to
eventual tolerance of less heated milk and ultimately unheated milk.
tolerance through frequent dose-escalation every 6 months versus 12 months leading to
eventual tolerance of less heated milk and ultimately unheated milk.
Milk is among the most common food allergens in infants and children. The majority of
children outgrow their milk allergies; however, the exact mechanisms by which food tolerance
is achieved are unknown. Strict avoidance of the offending food is currently the only known
therapy. However, some have been known to tolerate milk products cooked at high heat such as
when baked in foods.
This clinical trial involves a diet containing extensively baked milk protein to investigate
the effects of ingestion of heat-denatured milk on development of oral tolerance to
non-baked milk.
children outgrow their milk allergies; however, the exact mechanisms by which food tolerance
is achieved are unknown. Strict avoidance of the offending food is currently the only known
therapy. However, some have been known to tolerate milk products cooked at high heat such as
when baked in foods.
This clinical trial involves a diet containing extensively baked milk protein to investigate
the effects of ingestion of heat-denatured milk on development of oral tolerance to
non-baked milk.
Inclusion Criteria:
One or more of the following inclusion criteria for enrollment in the study have to be
met:
- Convincing history of an allergic reaction to milk or a positive double blind placebo
controlled milk challenge (DBPCMC) within the past 2 years and either detectable milk
immunoglobulin E (IgE) or positive prick skin test to milk OR
- Serum milk-IgE of high predictive value >14 kUa/L or prick skin test to milk > 10mm
wheal within the past 6 months regardless of past clinical history of reactions OR
- Convincing history of an allergic reaction to milk or a positive DBPCMC more than 2
years ago and either a positive serum milk-IgE < 14 kUA/L or positive prick skin test
to milk < 10 mm wheal within the past 6 months (eligible only for the active arm of
the study and will undergo a reversed sequence of initial baked-milk challenges)
Exclusion Criteria:
- Inability or unwillingness of a participant to give written informed consent or to
comply with study protocol
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