Cow's Milk Allergy Clinical Trial
Oral immunotherapy (OIT) programs for milk, egg and peanut, desensitize patients to their
respective allergens and thereby decrease their risk of morbidity and mortality. OIT
programs, however, are not without adverse events, particularly in highly sensitive
patients. Recently, it has been demonstrated that the administration of baked milk (BM)
products to IgE-CMA patients that are non-reactive to BM, can promote tolerance to unheated
milk (UM). The goal of our research is to determine whether BM can promote desensitization
even in the highly sensitive patient, who reacts to baked milk as well. In a second step, we
hypothesize BM-OIT will promote desensitization to unheated milk, as well.
Importance: The change in the risk/benefit ratio of such a program will alter the
therapeutic approach to an IgE-CMP allergic patient.
Probable implications to Medicine: BM-OIT will allow highly sensitive patients to tolerate
milk products, decreasing their risk of life-threatening reactions. Furthermore, analysis of
the immune modulation parameters that change during the treatment program, should pave the
way for defining mechanisms underlying tolerance in CMP allergy.
In our first aim, we will test over a four day induction (escalating) program, whether
highly sensitive UM-reactive patients) can tolerate BM . Those successful will be randomized
to a treated BM-OIT group (group A) and an observational control group (group B). In the
second aim, the fraction of patients in Group A who successfully progress in BM-OIT
(tolerate ≥ 360 mg BM) over a 6 month period will be determined and compared to the fraction
of patients in Group B who can tolerate 360mg. The results will also be compared to the
progression of highly sensitive IgE-CMA patients on UM-OIT (Group C, reactive to ≤21 mg of
UM ). In aim-3, the fraction of BM-OIT patients able to tolerate minimally ≥ 12.5 mg of UM
or higher than their initially eliciting dose. will be assessed.
Methods: Severe patients (>4 years) with a positive clinical history, SPT and a positive
DBPCFC to CMP will be first tested for their ability to tolerate BM. The treatment group
will undergo three rounds of oral induction, each consisting of 4 days and performed every 4
weeks. On day #1, the patient will be rapidly desensitized up to their threshold. On days
2-3, the maximum tolerable dose and interval is determined. Day #4 mimics the home
treatment. Home treatment will then continue until the next induction. After 6 months of
treatment patients will be evaluated for reactivity to UM.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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