Oral Immunotherapy for Peanut and Mammalian Meat Allergies
1 other identifier
interventional
24
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2012
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedFirst Submitted
Initial submission to the registry
January 21, 2015
CompletedFirst Posted
Study publicly available on registry
January 30, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedResults Posted
Study results publicly available
November 3, 2020
CompletedNovember 3, 2020
November 1, 2020
2.5 years
January 21, 2015
May 10, 2016
November 2, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Cow's milk for alpha-gal allergics
EXPERIMENTALdaily consumption of cow's milk
Peanut powder
EXPERIMENTALpeanut oral immunotherapy
Interventions
Eligibility Criteria
You may qualify if:
- Presence or absence of specific IgE to alpha-gal or peanut
You may not qualify if:
- History of severe anaphylaxis
- allergy to cow's milk protein
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Virginia
Charlottesville, Virginia, 22908, United States
Related Publications (1)
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.
PMID: 25823600DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Unblinded and without placebo control
Results Point of Contact
- Title
- Department of Medicine and Pediatrics
- Organization
- University of Virginia
Study Officials
- PRINCIPAL INVESTIGATOR
Scott Commins, MD
University of Virginia
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor, Department of Medicine, Allergy and Immunology
Study Record Dates
First Submitted
January 21, 2015
First Posted
January 30, 2015
Study Start
March 1, 2012
Primary Completion
September 1, 2014
Study Completion
June 1, 2015
Last Updated
November 3, 2020
Results First Posted
November 3, 2020
Record last verified: 2020-11