Oral Peanut Immunotherapy for Peanut Allergic Patients (PnOIT)
|ClinicalTrials.gov Identifier: NCT01891136|
Recruitment Status : Completed
First Posted : July 2, 2013
Last Update Posted : June 25, 2015
|Condition or disease||Intervention/treatment||Phase|
|Peanut Hypersensitivity||Drug: Peanut protein||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||36 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study: Oral Peanut Immunotherapy for Peanut Allergic Patients|
|Study Start Date :||April 2004|
|Actual Primary Completion Date :||November 2014|
|Actual Study Completion Date :||December 2014|
Experimental: Peanut protein
Subjects to receive varying amounts of peanut protein as peanut oral immunotherapy.
Drug: Peanut protein
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 Name: Peanut OIT
- The percentage of peanut-allergic patients achieving clinical desensitization to peanut, assessed after up to five years of 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.
- Clinical desensitization will be measured with an oral peanut challenge 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.
- Changes in number of antigen-specific lymphocytes. [ 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.
- Changes in function of antigen-specific lymphocytes. [ 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.
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): NCT01891136
|United States, North Carolina|
|UNC Chapel Hill|
|Chapel Hill, North Carolina, United States, 27599|
|Principal Investigator:||Wesley Burks, MD||UNC Chapel Hill|