Use of Baked Milk in Oral Immunotherapy for Severe IgE-mediated Cow's Milk Protein Allergic Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01968278
Recruitment Status : Unknown
Verified October 2013 by Assaf Harofeh MC, Assaf-Harofeh Medical Center.
Recruitment status was:  Recruiting
First Posted : October 24, 2013
Last Update Posted : October 24, 2013
Information provided by (Responsible Party):
Assaf Harofeh MC, Assaf-Harofeh Medical Center

Brief Summary:

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.

Condition or disease Intervention/treatment
Cow's Milk Allergy Other: Baked milk

Detailed Description:

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : January 2013
Estimated Primary Completion Date : November 2014

Arm Intervention/treatment
Experimental: Baked milk group
BM (baked milk)
Other: Baked milk
No Intervention: Control
IgE-cow's milk allergic patients not treated with OIT

Primary Outcome Measures :
  1. The amount of milk protein (mg) that can be tolerated as baked milk in highly sensitized CMA patietns [ Time Frame: Day 1 ]

Secondary Outcome Measures :
  1. The increase in tolerated CMP (mg) following 6 month of OIT in comparison to an observational control group kept on a CMP free diet [ Time Frame: one year ]

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Ages Eligible for Study:   4 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01968278

Contact: Yitzhak Katz, MD 972-8-9779820

Asaf Harofeh Medical Center Recruiting
Beer Yaakoc, Zerifin, Israel, 70300
Contact: Yitzhak Katz, MD    972-8-9779820   
Principal Investigator: Yitzhak Katz, MD         
Sponsors and Collaborators
Assaf-Harofeh Medical Center

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Assaf Harofeh MC, Helsinki commitee, Assaf-Harofeh Medical Center Identifier: NCT01968278     History of Changes
Other Study ID Numbers: 39/12 Asaf
First Posted: October 24, 2013    Key Record Dates
Last Update Posted: October 24, 2013
Last Verified: October 2013

Additional relevant MeSH terms:
Milk Hypersensitivity
Food Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases