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Oral Immunotherapy for Peanut and Mammalian Meat Allergies

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ClinicalTrials.gov Identifier: NCT02350660
Recruitment Status : Completed
First Posted : January 30, 2015
Last Update Posted : December 16, 2015
Sponsor:
Information provided by (Responsible Party):
Scott Commins, MD, University of Virginia

Brief Summary:
Pilot study to assess the effect of oral immunotherapy on specific IgE levels and antigen consumption in two distinct food allergies.

Condition or disease Intervention/treatment Phase
Food Hypersensitivity Dietary Supplement: cow's milk Dietary Supplement: peanut powder Not Applicable

Detailed Description:
In subjects with mammalian meat allergy, the effect of daily oral cow's milk on immune parameters and desensitization will be assessed. Similarly, in subjects with a peanut allergy the effects of low dose peanut flour will be assessed and comparisons between two distinct food allergies.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Oral Immunotherapy for Peanut and Mammalian Meat Allergies
Study Start Date : March 2012
Actual Primary Completion Date : September 2014
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cow's milk for alpha-gal allergics
daily consumption of cow's milk
Dietary Supplement: cow's milk
daily consumption of cow's milk

Experimental: Peanut powder
peanut oral immunotherapy
Dietary Supplement: peanut powder
peanut oral immunotherapy




Primary Outcome Measures :
  1. The level of allergen specific IgE present pre- and post-oral immunotherapy [ Time Frame: Participants will be followed for the duration of maintenance oral immunotherapy, an expected average of 36 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Presence or absence of specific IgE to alpha-gal or peanut

Exclusion Criteria:

  • History of severe anaphylaxis
  • allergy to cow's milk protein

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): NCT02350660


Locations
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United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
University of Virginia
Investigators
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Principal Investigator: Scott Commins, MD University of Virginia

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Scott Commins, MD, Associate Professor, Department of Medicine, Allergy and Immunology, University of Virginia
ClinicalTrials.gov Identifier: NCT02350660     History of Changes
Other Study ID Numbers: 15098
First Posted: January 30, 2015    Key Record Dates
Last Update Posted: December 16, 2015
Last Verified: December 2015

Additional relevant MeSH terms:
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Hypersensitivity
Food Hypersensitivity
Immune System Diseases
Hypersensitivity, Immediate
Immunologic Factors
Physiological Effects of Drugs