MedTrace Logo

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

NCT01968278 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2013-10-24

No results posted yet for this study

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

Interventions

OTHER

Baked milk

Sponsors & Collaborators

  • Assaf-Harofeh Medical Center

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
4 Years
Max Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2014-11-30

Countries

  • Israel

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01968278 on ClinicalTrials.gov