UNC Chapel Hill
Chapel Hill, North Carolina, 27599, United States
NCT Number: NCT01891136
This is a study to determine if peanut oral immunotherapy (OIT) would desensitize or tolerize peanut allergic patients to peanuts in order prevent peanut allergic reactions.
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Notify Me1 year–16 year
All sexes
Interventional
Early Phase 1
Chapel Hill, North Carolina, 27599, United States
The goal of this proposal is to develop peanut OIT for patients with peanut allergic reactions. This approach is designed to utilize our extensive knowledge of the allergens involved in peanut hypersensitivity to devise an immunotherapeutic approach that would lower the risk of anaphylactic reactions and would down regulate peanut-specific T cells in peanut-allergic patients. Previous attempts to utilize peanut-specific immunotherapy (IT) have been unsuccessful primarily because of the side effects of therapy.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Subjects will receive increasing amounts of peanut protein over the modified rush phase and the build-up phase of the protocol. Once the subject reaches the maintenance phase of the study, they will remain on that dose until they reach the oral food challenges at the end of the study.
Other names: Peanut OIT
Time frame: 2 to 5 years
Clinical desensitization will be measured with an oral food challenge (OFC) to peanut conducted while on OIT therapy.
Time frame: 2 to 5 years
Clinical tolerance will be measured with an oral peanut challenge conducted four weeks after discontinuing OIT.
Time frame: 2 to 5 years
The investigators will examine the role of OIT on peanut-specific T cell responses by enumerating specific T cell subsets, including T regulatory cells, pre- and post-treatment.
Time frame: 2-5 years
The investigators will examine the role of OIT on peanut-specific T cell responses by analyzing cell signaling, gene expression, and cytokine production, pre- and post-treatment.
University of North Carolina, Chapel Hill
Other
Pilot Study: Oral Peanut Immunotherapy for Peanut Allergic Patients
Acronym: PnOIT
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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