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

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Milk Hypersensitivity

In brief

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.

Key facts

Study ID

NCT00465569

Run by

Johns Hopkins University

People needed

20

Starts

2006-08-01

Expected to finish

2008-06-01

Last updated by the study team

2017-04-20

Who can join

Age: 6 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• The Johns Hopkins Hospital — Baltimore, Maryland, United States
• Duke University — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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