Cow's Milk Allergy Clinical Trial
NCT number | NCT01968278 |
Other study ID # | 39/12 Asaf |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | August 25, 2013 |
Last updated | October 20, 2013 |
Start date | January 2013 |
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.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | |
Est. primary completion date | November 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 4 Years to 30 Years |
Eligibility |
Inclusion Criteria: Patients with IgE-cow's milk allergy reacting to <12.5 mg (any reaction) on oral food challenge to unheated milk Exclusion Criteria: Patients with unstable asthma** or those with suspected compliance issues will be excluded. Patients with stable asthma are included. - defined as active wheezing and/or use of oral steroids within one month prior to initiation of program and/or FEV1<75% or a greater than 18% increase in FEV1 after bronchodilator treatment. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Israel | Asaf Harofeh Medical Center | Beer Yaakoc | Zerifin |
Lead Sponsor | Collaborator |
---|---|
Assaf-Harofeh Medical Center |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The amount of milk protein (mg) that can be tolerated as baked milk in highly sensitized CMA patietns | Day 1 | No | |
Secondary | The increase in tolerated CMP (mg) following 6 month of OIT in comparison to an observational control group kept on a CMP free diet | one year | No |
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