Milk Oral Immunotherapy in Children to Treat Food Allergy

Early Phase 1

Completed

Conditions: Milk Hypersensitivity

Interventions: Dietary Supplement: Milk Oral Immunotherapy
Drug: Milk Protein Powder
Other: Food Challenge

Registration Number: NCT01162473

Lead Sponsor: Children's Hospital of Philadelphia

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 25

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Immediate Sensitivity	Milk Oral Immunotherapy	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.
Delayed Sensitivity	Milk Oral Immunotherapy	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.
Delayed Sensitivity	Milk Protein Powder	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.
Delayed Sensitivity	Food Challenge	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.
Immediate Sensitivity	Milk Protein Powder	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.
Immediate Sensitivity	Food Challenge	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.

Primary Outcome Measures

Name	Time	Method
Number of Subjects Who Completed Desensitization Protocol	1 year	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".

Secondary Outcome Measures