Back to resultsOral Immunotherapy for Peanut and Mammalian Meat Allergies
Primary Purpose
Food Hypersensitivity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
cow's milk
peanut powder
Sponsored by
About this trial
This is an interventional treatment trial for Food Hypersensitivity
Eligibility 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
Sites / Locations
- University of Virginia
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Cow's milk for alpha-gal allergics
Peanut powder
Arm Description
daily consumption of cow's milk
peanut oral immunotherapy
Outcomes
Primary Outcome Measures
The Level of Allergen Consumed Post-oral Immunotherapy
consumption of cow's milk or peanut flour at open challenge. This is a single time-point assessment; not measured repeatedly.
Secondary Outcome Measures
Full Information
NCT ID
NCT02350660
First Posted
January 21, 2015
Last Updated
November 2, 2020
Sponsor
University of Virginia
1. Study Identification
Unique Protocol Identification Number
NCT02350660
Brief Title
Oral Immunotherapy for Peanut and Mammalian Meat Allergies
Official Title
Oral Immunotherapy for Peanut and Mammalian Meat Allergies
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
June 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Virginia
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Pilot study to assess the effect of oral immunotherapy on specific Immunoglobulin E (IgE) levels and antigen consumption in two distinct food allergies.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Food Hypersensitivity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cow's milk for alpha-gal allergics
Arm Type
Experimental
Arm Description
daily consumption of cow's milk
Arm Title
Peanut powder
Arm Type
Experimental
Arm Description
peanut oral immunotherapy
Intervention Type
Dietary Supplement
Intervention Name(s)
cow's milk
Intervention Description
daily consumption of cow's milk
Intervention Type
Dietary Supplement
Intervention Name(s)
peanut powder
Intervention Description
peanut oral immunotherapy
Primary Outcome Measure Information:
Title
The Level of Allergen Consumed Post-oral Immunotherapy
Description
consumption of cow's milk or peanut flour at open challenge. This is a single time-point assessment; not measured repeatedly.
Time Frame
Following 36 months of maintenance oral immunotherapy, participants completed an open challenge at month 37
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott Commins, MD
Organizational Affiliation
University of Virginia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
25823600
Citation
Wisniewski JA, Commins SP, Agrawal R, Hulse KE, Yu MD, Cronin J, Heymann PW, Pomes A, Platts-Mills TA, Workman L, Woodfolk JA. Analysis of cytokine production by peanut-reactive T cells identifies residual Th2 effectors in highly allergic children who received peanut oral immunotherapy. Clin Exp Allergy. 2015 Jul;45(7):1201-13. doi: 10.1111/cea.12537.
Results Reference
derived
Learn more about this trial
Oral Immunotherapy for Peanut and Mammalian Meat Allergies
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