The Effect of Baked Milk on Cow's Milk Allergy

April 23, 2018 updated by: Hossein Esmaielzadeh

Efficacy of Baked Milk in Accelerating Resolution of Cow's Milk Allergy

To investigate the effect of baked milk in immunotherapy of cow's milk allergy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Food allergy, as an immune based hypersensitivity reaction, is estimated to be about 6% in young children and 3-4% in adults [1, 2]. Its pathophysiology is defined trough both IgE and non-IgE mediated mechanisms, which lead to skin, gastrointestinal, respiratory and systemic manifestations [1]. This type of allergy is mostly seen trough the first year of life. One study showed that about 2.5% of the neonates show allergy to cow's milk [3].

Most of food allergens are cow's milk, chicken egg, corn, soya, peanut, dried fruits, and fishes. Among them, cow's milk is considered to be the most common one, specifically, among the children [1, 2].

This allergen consists of about 20 proteins which all can induce immune system to produce antibodies. The two major protein components of milk are casein and whey. About 76 to 86% of it is casein, which is responsible for the IgE mediated immune response. On the other hand, whey, which is composed of alpha-lactalbumin, beta-lactoglobulin, and albumin, is mostly induced systemic allergic reactions [4].

Boiling the milk at 95 c for 20 minutes can damage some whey's protein components; however, it cannot damage the major milk's allergens. Pasteurization is also shown to have no effect on these allergens [5].

It was shown that IgE mediated mechanisms are involved in lifelong cow's milk allergy. In spite of that, about 50% of children up to 1 year old and 85% up to 3 years old develop by tolerance to milk's allergen [6].

Oral food challenge (OFC) test confirming by skin prick test and serum IgE levels is one of the most sensitive tools for diagnosis of food allergy. It was shown to have sensitivity about 95 % and specificity about 50%[7].

Comparing baked milk and non-heated milk allergy was shown that ones with allergy to baked milk have more chance of developing anaphylactic reactions. Some studies on patients who can tolerate baked milk suggest that adding these products to the daily diet of sensitive children can improve tolerance to cow's milk [8, 9]. On the other hand, another study in Australia showed that phenotype is the strongest predictor of tolerance development and altered allergen such as baked milk does not have significant effect in this process [10].

Thus, according to the controversies on effect of baked milk in immunotherapy of cow's milk allergy as well as the necessity of developing a safe method of milk's allergy due to high risk of anaphylactic reactions to milk's products in patients, it seems to be essential to perform a study assessing the possibility of tolerance induction by baked milk in cow's milk allergic children.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iran, Islamic Republic of
    • Fars
      • Shiraz, Fars, Iran, Islamic Republic of, 7186767431
        • Imam Reza Allergy and Immunology clinic, Shiraz University of Medical Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 14 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. The patients' ages between 6 months to 18 years old.
  2. Having positive histories of cow's milk allergy presenting by dermal, gastrointestinal, respiratory or systemic manifestations.
  3. Confirmed cow's milk allergy by standard diagnostic tools such as skin prick test more than 8 millimeters or serum IgE levels higher than 5 KIU/L up to 2 years old and 15 KIU/L in other ages.
  4. Cases who have tolerance to baked milk products confirmed by oral food challenge test.

Exclusion Criteria:

  1. Ones with low serum IgE levels and negative skin prick test for milk products.
  2. Ones with positive histories of unstable asthma.
  3. Ones with eosinophilic gastrointestinal disorders.
  4. Ones with history of allergy to baked milk products in last 6 months.
  5. Ones with positive history of severe anaphylactic reaction to milk and its products in last 6 months.
  6. Ones with positive allergy history to chicken egg or wheat.
  7. Patients with celiac disease.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Case group
The patients in case group will be received baked milk daily in the form of muffin for 6 months. They will be visited weekly in the first month and every 2 weeks in other 5 months. At the end of the 6 months, the patients will undergo oral food challenge by 30 grams baked cheese in the form of pizza cheese. If the test will be negative, they will receive pizza cheese 4 or 7 days per week for other 6 months. The patients will be followed every 2 weeks during this period.
Dietary supplement: Baked Milk

The patients in case group will be received baked milk daily in the form of muffin(30 cc milk (equal to 1/3 of milk's proteins) heated in 350 F or 180 C for 30 mints) for 6 months. They will be visited weekly in the first month and every 2 weeks in other 5 months. At the end of the 6 months, the patients will undergo oral food challenge by 30 grams baked cheese in the form of pizza cheese. If the test will be negative, they will receive pizza cheese 4 or 7 days per week for other 6 months. The patients will be followed every 2 weeks during this period.

Skin prick test and serum IgE levels will be done at the beginning of the study, at 6 and 12 months. IgG4, being specific for milk allergens, will also measured at the beginning and at 12 months of the study.

Other Names:
  • muffin
  • pizza cheese
  • baked milk products

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tolerance to cow's milk assessed by oral food challenge test
Time Frame: 1 month
oral food challenge test is done for cow's milk products
1 month

Secondary Outcome Measures

Outcome Measure
Time Frame
Tolerance to cow's milk by measuring serum specific IgE levels
Time Frame: 1 month
1 month
Tolerance to cow's milk using skin prick test
Time Frame: 1 month
1 month
Tolerance to cow's milk by measuring serum IgG4
Time Frame: 1 month
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hossein Esmaielzadeh

Collaborators

Shiraz University of Medical Sciences

Investigators

  • Study Director: Hossein Esmaeilzadeh, 1.Allergy Research Center, Shiraz University of Medical Sciences, Shiraz, Iran. 2.Department of Allergy and Immunology, Namazi Hospital, Shiraz University of Medical Sciences, Shiraz, Iran

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Actual)

March 1, 2017

Study Completion (Actual)

April 1, 2017

Study Registration Dates

First Submitted

April 5, 2016

First Submitted That Met QC Criteria

April 9, 2016

First Posted (Estimate)

April 14, 2016

Study Record Updates

Last Update Posted (Actual)

April 25, 2018

Last Update Submitted That Met QC Criteria

April 23, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9401359338

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

The personal data of patients will not be recorded in written article. Only the result of the study will be recorded.

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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