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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00465569
Recruitment Status : Completed
First Posted : April 25, 2007
Results First Posted : April 20, 2017
Last Update Posted : April 20, 2017
Duke University
Information provided by (Responsible Party):
Johns Hopkins University

April 23, 2007
April 25, 2007
February 17, 2017
April 20, 2017
April 20, 2017
August 2006
June 2008   (Final data collection date for primary outcome measure)
The Median Milk Threshold Dose Inducing a Reaction [ Time Frame: Baseline and 23 weeks ]
The percentage of patients who can tolerate four times the initial OFC threshold dose or the maximum OFC dose of 8 grams after therapy.
Complete list of historical versions of study NCT00465569 on Archive Site
  • Changes in Cow Milk-IgE [ Time Frame: Baseline and 23 weeks ]
    IgE is measured in kilounits per liter (kU/L). Measurements were obtained at Baseline and at 23 weeks
  • Changes in Cow Milk Immunoglobulin G4 (IgG4) [ Time Frame: Baseline and 23 weeks ]
    IgG4 is measured in ug/mL. Measurements were obtained at Baseline and at 23 weeks
  • Incidence of protocol-defined severe hypersensitivity reactions during the study
  • Incidence of all serious adverse events during the study
  • Incidence of all adverse events
  • To assess for any changes in milk-IgE, milk-IgG4, and skin test reactivity during OIT and as milk allergy persists or resolves.
Not Provided
Not Provided
A Randomized, Double-Blind, Placebo-Controlled Study of Oral Milk Immunotherapy for Cow's Milk Allergy
A Randomized, Double-Blind, Placebo-Controlled Study of Oral Milk Immunotherapy for Cow's Milk Allergy
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.
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.
Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Milk Hypersensitivity
  • Drug: cow's milk powder
    Milk powder given orally in escalating doses to a goal of 500 mg for approximately 23 weeks
  • Other: Placebo
  • Experimental: Active Treatment
    Pre-measured doses of dry, nonfat powered milk prepared by the clinical research-registered dieticians
    Intervention: Drug: cow's milk powder
  • Placebo Comparator: Placebo
    Intervention: Other: Placebo

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
June 2008
June 2008   (Final data collection date for primary outcome measure)

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
  • 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

Sexes Eligible for Study: All
6 Years to 21 Years   (Child, Adult)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Johns Hopkins University
Johns Hopkins University
Duke University
Principal Investigator: Robert A Wood, MD Johns Hopkins University
Johns Hopkins University
April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP