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Sponsors and Collaborators: |
Johns Hopkins University Duke University Greer Laboratories |
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Information provided by: | Johns Hopkins University |
ClinicalTrials.gov Identifier: | NCT00732654 |
The purpose of this study is to determine if small oral and sublingual doses of milk protein are safe and effective in decreasing sensitivity to cow's milk in allergic children.
Condition | Intervention | Phase |
---|---|---|
Milk Allergy |
Drug: Milk Protein Extract Immunotherapy Drug: Milk Powder Immunotherapy |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | The Safety and Efficacy of Sublingual/Oral Immunotherapy for the Treatment of Milk Protein Allergy |
Estimated Enrollment: | 30 |
Study Start Date: | August 2008 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
These subjects will start with a dose escalation of the milk protein extract given sublingually, and then will switch to milk powder given orally and will undergo a dose escalation for a goal of 2000 mg. After dose escalation, they will continue on the oral daily maintenance dose for approximately one year.
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Drug: Milk Protein Extract Immunotherapy
Sublingual extract given daily in escalating doses with goal of 4 mg/day for approximately 20 weeks.
Drug: Milk Powder Immunotherapy
Milk powder given orally in escalating doses with a goal dose of 2000mg/day given for approximately 1 1/2 years.
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2: Experimental
These subjects will start with a dose escalation of the milk protein extract given sublingually, and then will switch to milk powder given orally and will undergo a dose escalation for a goal of 1000 mg. After dose escalation, they will continue on the oral daily maintenance dose for approximately one year.
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Drug: Milk Protein Extract Immunotherapy
Sublingual extract given daily in escalating doses with goal of 4 mg/day for approximately 20 weeks.
Drug: Milk Powder Immunotherapy
Milk powder given orally in escalating doses with a goal of 1000mg/day for approximately 1 1/2 years.
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3: Experimental
These subjects will have a dose escalation of the milk protein extract given sublingually. After dose escalation, they will continue on the sublingual daily maintenance dose for approximately one year.
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Drug: Milk Protein Extract Immunotherapy
Sublingual extract daily in escalating doses to goal of 7mg/day for approximately 1 1/2 years.
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Ages Eligible for Study: | 6 Years to 21 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Life-threatening anaphylaxis, or Reaction requiring hospitalization
Contact: Corinne A Keet, MD | (410) 955-5883 | pediatricallergy@jhmi.edu |
United States, Maryland | |
Johns Hopkins Hospital | Recruiting |
Baltimore, Maryland, United States, 21287 | |
Contact: Corinne A. Keet, MD 410-955-5883 | |
Principal Investigator: Robert A Wood, MD | |
United States, North Carolina | |
Duke University | Not yet recruiting |
Durham, North Carolina, United States, 27710 | |
Sub-Investigator: Wesley Burks, M.D. |
Principal Investigator: | Robert Wood, MD | Johns Hopkins |
Responsible Party: | Johns Hopkins School of Medicine ( Robert Wood M.D. ) |
Study ID Numbers: | NCT00014511 |
Study First Received: | August 8, 2008 |
Last Updated: | August 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00732654 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Food Allergy Oral Immunotherapy Immunoglobulin E |
Antibodies Food Hypersensitivity Hypersensitivity |
Milk Hypersensitivity Hypersensitivity, Immediate Immunoglobulins |
Food Hypersensitivity Hypersensitivity Immune System Diseases Milk Hypersensitivity Hypersensitivity, Immediate |