Milk Oral Immunotherapy in Children to Treat Food Allergy

Study Overview
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Brief Summary
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Background and Rationale For patients with Immunoglobulin E (IgE)-mediated food allergy, the current management includes identification of the causative food and avoidance. Specifically, among young children, cow's milk allergy is the most common food allergy, occurring in as many as 2-3%. Given the prevalence of milk and the difficulty to avoid it in the diet, the investigators aim to investigate the safety and efficacy of oral immunotherapy for cow's milk allergy. Main Objective The primary objective is to study the efficacy of milk oral immunotherapy. Target Population Children aged six to 17 years with a history of cow's milk allergy will be recruited from The Children's Hospital of Philadelphia Allergy clinical offices for the investigators study.

Detailed Description
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Primary Study Interventions Prior to and after the desensitization, we will conduct double-blind placebo controlled food challenges to cow's milk protein. During the desensitization phase, we will give increasing doses of cow's milk protein by mouth on a weekly basis, as tolerated. The desensitization protocol starts with dilutional doses of milk and build up to a goal of 8 ounces of cow's milk. Main Study Outcome Measure The percentage of children completing the desensitization protocol in each study group will be the primary outcome measure.

Official Title
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A Study of the Efficacy of Milk Oral Immunotherapy in Children

Conditions
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Milk Hypersensitivity

Intervention / Treatment
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* Dietary Supplement: Milk Oral Immunotherapy
* Drug: Milk Protein Powder
* Other: Food Challenge


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects must be age six to 17 years and have a history of cow's milk allergy. Subjects shall maintain strict avoidance of consumption of all cow's milk protein containing foods. Subjects will have a history (within the past six months) of a positive skin prick test to milk extract or an immunocap IgE level greater than 0.35 kilounits per liter (kU/L), and a positive allergic reaction history to milk within the past 12 months. Subjects must be in good health, as determined by medical history and physical examination performed by a study physician. Females of childbearing potential must be using an effective method of contraception, including abstinence, and agree to continue to practice an acceptable method of contraception for the duration of their participation in the study. Informed consent of parent or legal guardian is required. Exclusion Criteria: Ability to tolerate eight ounces of cow's milk or eight grams of milk protein powder Pregnancy A history of soy allergy A history of food protein induced enterocolitis syndrome to milk A history of anaphylaxis requiring hospitalization A history of intubation related to asthma and/or a history of an intensive care unit admission for asthma management A current diagnosis of severe persistent asthma [forced expiratory volume in 1 second (FEV1) < 60% of predicted, as defined by National Heart, Lung, and Blood Institute (NHLBI) guidelines, despite current therapy A current diagnosis of severe atopic dermatitis A serious chronic medical condition, including neurologic, hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, or metabolic disease Use of oral or injection steroids within one month of protocol initial visit An acute illness within one week prior to the first dose of oral immunotherapy Use of antihistamines within seven days prior to double blind placebo controlled food challenge (DBPCFC) Use of chronic immunomodulatory therapy Participation in another experimental therapy study Participation in a study for the treatment of food allergy in the past 12 months Inability to discontinue antihistamines for skin testing and food challenges

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Delayed Sensitivity<br>All subjects will undergo a food challenge (week 2). Subjects undergoing delayed desensitization via milk oral immunotherapy with milk protein powder will begin build-up of desensitization during Week 16 and continue thru Week 50. Total active participation will last 51 weeks. | Dietary Supplement: Milk Oral Immunotherapy<br>* Subjects will participate in a desensitization protocol over the course of 13 weeks to reach a goal maintenance dose of 8 ounces of cow's milk. Once reaching maintenance, subjects will continue on this dose for 12 additional weeks.<br>Drug: Milk Protein Powder<br>* Milk protein powder will be administered in incremental doses during the desensitization protocol.<br>Other: Food Challenge<br> <br> |
| Active Comparator: Immediate Sensitivity<br>All subjects will undergo a food challenge (week 2). Subjects undergoing immediate desensitization via milk oral immunotherapy with milk protein powder will begin build-up of desensitization during Week 3 and continue thru Week 35. Total active participation will last 38 weeks. | Dietary Supplement: Milk Oral Immunotherapy<br>* Subjects will participate in a desensitization protocol over the course of 13 weeks to reach a goal maintenance dose of 8 ounces of cow's milk. Once reaching maintenance, subjects will continue on this dose for 12 additional weeks.<br>Drug: Milk Protein Powder<br>* Milk protein powder will be administered in incremental doses during the desensitization protocol.<br>Other: Food Challenge<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects Who Completed Desensitization Protocol | Subjects who withdrew prior to completing the desensitization protocol and those who experienced anaphylaxis during the desensitization protocol (i.e., were unable to complete the protocol) were considered to be treatment failures. Subjects who completed the desensitization protocol were considered to be treatment successes. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Food hypersensitivity, Milk hypersensitivity, Milk allergy, Food allergy