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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00465569
First Posted: April 25, 2007
Last Update Posted: April 20, 2017
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.
Collaborator:
Duke University
Information provided by (Responsible Party):
Johns Hopkins University
  Purpose
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.

Condition Intervention Phase
Milk Hypersensitivity Drug: cow's milk powder Other: Placebo Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Study of Oral Milk Immunotherapy for Cow's Milk Allergy

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • The Median Milk Threshold Dose Inducing a Reaction [ Time Frame: Baseline and 23 weeks ]

Secondary Outcome Measures:
  • 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


Enrollment: 20
Study Start Date: August 2006
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active Treatment
Pre-measured doses of dry, nonfat powered milk prepared by the clinical research-registered dieticians
Drug: cow's milk powder
Milk powder given orally in escalating doses to a goal of 500 mg for approximately 23 weeks
Placebo Comparator: Placebo Other: Placebo

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • 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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00465569


Locations
United States, Maryland
The Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
United States, North Carolina
Duke University
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Johns Hopkins University
Duke University
Investigators
Principal Investigator: Robert A Wood, MD Johns Hopkins University
  More Information

Publications:
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00465569     History of Changes
Other Study ID Numbers: NA_00002102
First Submitted: April 23, 2007
First Posted: April 25, 2007
Results First Submitted: February 17, 2017
Results First Posted: April 20, 2017
Last Update Posted: April 20, 2017
Last Verified: April 2017

Keywords provided by Johns Hopkins University:
Food Allergy
Oral Immunotherapy
Immunoglobulin E

Additional relevant MeSH terms:
Hypersensitivity
Milk Hypersensitivity
Immune System Diseases
Food Hypersensitivity
Hypersensitivity, Immediate