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

NCT01968278 | Unknown

• 1 other identifier: 39/12 Asaf
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Cow's Milk Allergy

Outcome Measures

Primary Outcomes (1)

• The amount of milk protein (mg) that can be tolerated as baked milk in highly sensitized CMA patietns

  Day 1

Secondary Outcomes (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

  one year

Study Arms (2)

Baked milk group

EXPERIMENTAL

BM (baked milk)

Other: Baked milk

Control

NO INTERVENTION

IgE-cow's milk allergic patients not treated with OIT

Interventions

Baked milk OTHER

Baked milk group

Eligibility Criteria

• Age: 4 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients with IgE-cow's milk allergy reacting to \<12.5 mg (any reaction) on oral food challenge to unheated milk

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assaf-Harofeh Medical Center: lead

Study Sites (1)

Asaf Harofeh Medical Center

Beer Yaakoc, Zerifin, 70300, Israel

RECRUITING

Related Publications (1)

• Goldberg MR, Nachshon L, Appel MY, Elizur A, Levy MB, Eisenberg E, Sampson HA, Katz Y. Efficacy of baked milk oral immunotherapy in baked milk-reactive allergic patients. J Allergy Clin Immunol. 2015 Dec;136(6):1601-1606. doi: 10.1016/j.jaci.2015.05.040. Epub 2015 Jul 17.

  PMID: 26194541 DERIVED

MeSH Terms

Conditions

Milk Hypersensitivity

Condition Hierarchy (Ancestors)

Food Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Central Study Contacts

Yitzhak Katz, MD

CONTACT

972-8-9779820; ykatz49@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Helsinki commitee

Study Record Dates

• First Submitted: August 25, 2013
• First Posted: October 24, 2013
• Study Start: January 1, 2013
• Primary Completion: November 1, 2014
• Last Updated: October 24, 2013

Record last verified: 2013-10

Locations

IL (1)