Status:
COMPLETED
A Randomized, Double-Blind, Placebo-Controlled Study of Oral Milk Immunotherapy for Cow's Milk Allergy
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
Duke University
Conditions:
Milk Hypersensitivity
Eligibility:
All Genders
6-21 years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to determine if small oral doses of milk protein are safe and effective in decreasing sensitivity to cow's milk in allergic children.
Detailed Description
This is a prospective, multi-center, clinical trial involving children aged 6 to 21 years with persistent cow's milk allergy. These children will be recruited from 2 sites (Johns Hopkins and Duke Univ...
Eligibility Criteria
Inclusion
- Provide signed informed consent (by parent or legal guardian if the subject is a minor) and informed assent if applicable
- Age 6 to 21 years
- Must have history of symptomatic reactivity to cow's milk (eczema, urticaria, upper/lower resp., GI, other associated rash, oral symptoms)
- History of positive skin prick test (wheal \>/= histamine control) or milk-Immunoglobulin E (IgE)\>0.35 kilounits per liter (kU/L)
- Positive DBPCFC
- All females of child bearing age must be using appropriate birth control
Exclusion
- History of anaphylaxis requiring hospitalization
- History of intubation related to asthma
- Has the ability to tolerate \>2.4gram of milk protein at initial DBPCFC
- Has a history of allergy to any component of vehicle
- Pregnancy (need negative test)
- Viral upper respiratory infection (URI) or gastroenteritis within 7days of OFC (OFC needs to be rescheduled)
- Has pulmonary function tests \<80% of predicted (FEV1) or clinical history consistent with moderate persistent asthma
- Currently taking greater than medium dose inhaled corticosteroid (\>400mcg/day fluticasone or fluticasone equivalent if \</=12yo or \>600mcg/day if \>12 years old)
- Antihistamine within 1 week prior to skin testing or food challenges (Skin testing and/or food challenge needs to be rescheduled)
- Systemic corticosteroid within 4 weeks prior to baseline visit
- Receiving omalizumab, beta-blocker, Angiotensin-converting enzyme (ACE) inhibitor or tricyclic antidepressant therapy
- Chronic disease (other than asthma, atopic dermatitis, rhinitis) requiring therapy (e.g., heart disease, diabetes)
- Participation in any interventional study for treatment of a food allergy in the past 12 months
- Severe reaction at initial DBPCFC, defined as:
- i. Life-threatening anaphylaxis ii. Requires overnight hospitalization
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00465569
Start Date
August 1 2006
End Date
June 1 2008
Last Update
April 20 2017
Active Locations (2)
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1
The Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
2
Duke University
Durham, North Carolina, United States, 27710