- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01968278
Use of Baked Milk in Oral Immunotherapy for Severe IgE-mediated Cow's Milk Protein Allergic Patients
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.
Study Overview
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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Yitzhak Katz, MD
- Phone Number: 972-8-9779820
- Email: ykatz49@gmail.com
Study Locations
-
-
Zerifin
-
Beer Yaakoc, Zerifin, Israel, 70300
- Recruiting
- Asaf Harofeh Medical Center
-
Contact:
- Yitzhak Katz, MD
- Phone Number: 972-8-9779820
- Email: ykatz49@gmail.com
-
Principal Investigator:
- Yitzhak Katz, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Baked milk group
BM (baked milk)
|
|
No Intervention: Control
IgE-cow's milk allergic patients not treated with OIT
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The amount of milk protein (mg) that can be tolerated as baked milk in highly sensitized CMA patietns
Time Frame: Day 1
|
Day 1
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
one year
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 39/12 Asaf
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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