Milk Oral Immunotherapy in Children to Treat Food Allergy

Completed · Early Phase 1

Conditions studied: Milk Hypersensitivity

In brief

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.

Key facts

Study ID

NCT01162473

Run by

Children's Hospital of Philadelphia

People needed

25

Starts

2010-06-01

Expected to finish

2013-12-01

Last updated by the study team

2015-05-13

Who can join

Age: 6 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• The Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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