Milk Oral Immunotherapy in Children to Treat Food Allergy
Milk Hypersensitivity
About this trial
This is an interventional treatment trial for Milk Hypersensitivity focused on measuring Food hypersensitivity, Milk hypersensitivity, Milk allergy, Food allergy
Eligibility Criteria
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
Sites / Locations
- The Children's Hospital of Philadelphia
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Delayed Sensitivity
Immediate Sensitivity
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.
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.