Peanut Oral Immunotherapy (OIT) - Initial Pilot Study in Adults
|ClinicalTrials.gov Identifier: NCT01274429|
Recruitment Status : Terminated (Lack of funding)
First Posted : January 11, 2011
Results First Posted : March 10, 2017
Last Update Posted : March 27, 2018
|Condition or disease||Intervention/treatment||Phase|
|Peanut Allergy||Drug: Peanut flour||Phase 1 Phase 2|
The goal of this proposal is to produce a new treatment that would benefit subjects who have peanut allergy by lowering the risk of anaphylactic reactions (desensitization), and changing the peanut-specific immune response in subjects who have peanut allergy (tolerance). This is a research study to test stimulation of the immune system to improve peanut allergy. The approach the investigators will use for peanut allergy is called desensitization. A person becomes desensitized to a food by taking small, increasing amounts of the food to help the body become used to the food so that it no longer causes a severe allergic reaction.
The study also looks at the safety and immune system effects of the investigational study product, peanut protein. The word "investigational" means the study product is still being tested in research studies and is not approved by the U.S. Food and Drug Administration (FDA).
This project is designed to study if peanut oral immunotherapy (POIT) will desensitize subjects with peanut hypersensitivity by regulating their oral and systemic immune reactivity and cause long-term tolerance.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Peanut Oral Immunotherapy (OIT) - Initial Pilot Study in Adults|
|Study Start Date :||December 2010|
|Actual Primary Completion Date :||November 2015|
|Actual Study Completion Date :||November 2015|
Experimental: Open label peanut flour
Orally ingested peanut flour administered in gradually increasing doses up to a maximum maintenance dose.
Drug: Peanut flour
Peanut flour that is ingested daily and administered in gradually increasing amounts up to a maximum maintenance dose.
Other Name: Peanut OIT
- Determine Whether This Peanut OIT Protocol Lowers Their Risk of Anaphylactic Reactions and Causes Long-term Tolerance. [ Time Frame: 2-3 years ]Assess mg of peanut tolerated on double-blind placebo-controlled food challenge as a measure of desensitization and tolerance
- Determine the Effect That PNOIT Has on the Peanut-specific Cellular and Humoral Response in Peanut-allergic Subjects. [ Time Frame: 2-3 years ]Measure changes over the course of treatment in serum specific IgE and IgG4, skin prick tests, TH1 and TH2 cytokines, and CD4+ CD25+ FoxP3+ regulatory T cells
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01274429
|United States, North Carolina|
|University of North Carolina|
|Chapel Hill, North Carolina, United States, 27599|
|Principal Investigator:||Wesley Burks, MD||Duke University|