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NCT02350660 Clinical Trial

Oral Immunotherapy for Peanut and Mammalian Meat Allergies

Food Hypersensitivity Clinical Trial

Official title:
Oral Immunotherapy for Peanut and Mammalian Meat Allergies

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02350660
Other study ID # 15098
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 2012
Est. completion date June 2015

Study information
Verified date November 2020
Source University of Virginia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Pilot study to assess the effect of oral immunotherapy on specific Immunoglobulin E (IgE) levels and antigen consumption in two distinct food allergies.

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.

Recruitment information / eligibility
Status Completed
Enrollment 24
Est. completion date June 2015
Est. primary completion date September 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 4 Years to 80 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• cow's milk
daily consumption of cow's milk
• peanut powder
peanut oral immunotherapy

Locations
Country Name City State
United States University of Virginia Charlottesville Virginia

Sponsors (1)
Lead Sponsor Collaborator
University of Virginia

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. Following 36 months of maintenance oral immunotherapy, participants completed an open challenge at month 37
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