A Randomized, Double-Blind, Placebo-Controlled Study of Oral Milk Immunotherapy for Cow's Milk Allergy
Overview
- Phase
- Phase 1
- Intervention
- cow's milk powder
- Conditions
- Milk Hypersensitivity
- Sponsor
- Johns Hopkins University
- Enrollment
- 20
- Locations
- 2
- Primary Endpoint
- The Median Milk Threshold Dose Inducing a Reaction
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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 University) and will undergo initial screening and double-blind, placebo-controlled, food challenge (DBPCFC) to confirm threshold dose for reactivity to milk. Patients will be treated with milk oral immunotherapy (OIT) or placebo for 22-30 weeks. Those who reach an adequate maintenance dose for OIT will undergo a second DBPCFC. Those who develop desensitization will continue with daily milk intake and undergo a third DBPCFC. Those in the treatment group who are not desensitized will return to strict avoidance. Those in placebo group will be offered to begin treatment or continue with strict milk avoidance. Symptom and diet information will be collected initially and at regular intervals. Bloodwork, skin prick tests (SPTs), pulmonary function tests (PFTs), and oral secretion samples will be done initially and at periodic intervals.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •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
Arms & Interventions
Active Treatment
Pre-measured doses of dry, nonfat powered milk prepared by the clinical research-registered dieticians
Intervention: cow's milk powder
Placebo
Intervention: Placebo
Outcomes
Primary Outcomes
The Median Milk Threshold Dose Inducing a Reaction
Time Frame: Baseline and 23 weeks
Secondary Outcomes
- Changes in Cow Milk-IgE(Baseline and 23 weeks)
- Changes in Cow Milk Immunoglobulin G4 (IgG4)(Baseline and 23 weeks)