An Interventional Study of Milk Allergy
Completed · Early Phase 1
Conditions studied: Food Hypersensitivity, Milk Hypersensitivity
In brief
Milk is the among the most common food allergens in infants and children. The majority of children outgrow their allergies; however, the exact mechanisms by which food tolerance is achieved are unknown. Strict avoidance of the offending food is currently the only known therapy. However, subjects have been known to lose food hypersensitivity while frequently ingesting small amounts of processed forms of the offending product. The purpose of this study is to investigate whether ingestion of small amounts of processed milk protein will be permitted without compromising the chances of either outgrowing milk hypersensitivity or prolonging the time needed to achieve clinical tolerance.
Key facts
- Study ID
- NCT00578656
- Run by
- National Institute of Allergy and Infectious Diseases (NIAID)
- People needed
- 220
- Starts
- 2004-06-01
- Expected to finish
- 2011-02-01
- Last updated by the study team
- 2012-08-01
Who can join
Age: 4 and older, up to 25. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Positive prick skin test to milk and/or detectable serum milk-IgE
- History of allergic reaction to milk within past 6 months
- Serum milk-IgE of high predictive value (>15 in children older than 1 year, >5 in children younger than 1 year)
- Asymptomatic or stabilized atopic disease (asthma, allergic rhinitis, atopic dermatitis) for a minimum of 7 days prior to OFC
You may not qualify if…
- Serum level of cow's milk-specific IgE antibody greater than 35 kIU/L
- History of anaphylactic reaction to cow's milk within the past 12 months
- Unstable asthma
- Allergic eosinophilic gastroenteritis caused by milk
- Use of short-acting antihistamines more than one time within 3 days of OFC
- Use of medium-acting antihistamines more than one time within 7 days of OFC
- Maintenance therapy or use of beta-blockers and ACE inhibitors within 12 to 24 hours of OFC
- Participation in study baked egg study GCO#03-0609 within 6 months of enrollment
- Pregnant
Where it is running
- Mount Sinai School of Medicine — New York, New York, United States
Full record on ClinicalTrials.gov
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