Milk Oral Immunotherapy in Children to Treat Food Allergy

Children's Hospital of Philadelphia (CHOP)

Status and phase: Completed; Early Phase 1

Conditions: Milk Hypersensitivity

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

Study type: Interventional

Funder types: Other

Identifiers

NCT01162473

09-007320

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 patients

Sex: All

Ages: 6 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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.
2. 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.
3. Subjects must be in good health, as determined by medical history and physical examination performed by a study physician.
4. 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.
5. Informed consent of parent or legal guardian is required.

Exclusion criteria

1. Ability to tolerate eight ounces of cow's milk or eight grams of milk protein powder
2. Pregnancy
3. A history of soy allergy
4. A history of food protein induced enterocolitis syndrome to milk
5. A history of anaphylaxis requiring hospitalization
6. A history of intubation related to asthma and/or a history of an intensive care unit admission for asthma management
7. 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
8. A current diagnosis of severe atopic dermatitis
9. A serious chronic medical condition, including neurologic, hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, or metabolic disease
10. Use of oral or injection steroids within one month of protocol initial visit
11. An acute illness within one week prior to the first dose of oral immunotherapy
12. Use of antihistamines within seven days prior to double blind placebo controlled food challenge (DBPCFC)
13. Use of chronic immunomodulatory therapy
14. Participation in another experimental therapy study
15. Participation in a study for the treatment of food allergy in the past 12 months
16. Inability to discontinue antihistamines for skin testing and food challenges

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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25 participants in 2 patient groups

Delayed Sensitivity

Active Comparator group

Description:

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.

Treatment:

Other: Food Challenge

Drug: Milk Protein Powder

Dietary Supplement: Milk Oral Immunotherapy

Immediate Sensitivity

Active Comparator group

Description:

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.

Treatment:

Other: Food Challenge

Drug: Milk Protein Powder

Dietary Supplement: Milk Oral Immunotherapy