Overview

A Randomized, Double-Blind, Placebo-Controlled Study of Oral Milk Immunotherapy for Cow's Milk Allergy

Status:
Completed
Trial end date:
2008-06-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Johns Hopkins University
Robert A. Wood
Collaborator:
Duke University
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 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