Status:
COMPLETED
Milk Oral Immunotherapy in Children to Treat Food Allergy
Lead Sponsor:
Children's Hospital of Philadelphia
Conditions:
Milk Hypersensitivity
Eligibility:
All Genders
6-17 years
Phase:
EARLY_PHASE1
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 ...
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 gi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT01162473
Start Date
June 1 2010
End Date
December 1 2013
Last Update
May 13 2015
Active Locations (1)
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1
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104