Back to resultsPeanut Oral Immunotherapy (OIT) - Initial Pilot Study in Adults
Primary Purpose
Peanut Allergy
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Peanut flour
Sponsored by
About this trial
This is an interventional treatment trial for Peanut Allergy focused on measuring Peanut allergy, Immunotherapy, OIT
Eligibility Criteria
Inclusion Criteria:
- Age 18 to 50 years of age of any gender, race, or ethnicity.
- Diagnosis of peanut allergy OR convincing clinical history of peanut allergy.
- Detectable serum peanut -specific Immune globin E(IgE) level (CAP-FEIA ≥ 0.35 kU/L) and a positive skin prick test (SPT) to peanut.
- Participant willing to use effective method of contraception if female for the duration of the study, not pregnant or lactating, and not planning to become pregnant.
- Positive reaction to ≤ 2 gm peanut protein on entry challenge.
Exclusion Criteria:
- History of severe anaphylaxis to peanut per current National Cancer Institute Common Toxicity Criteria for Adverse Effects (NCI-CTCAE) allergic reaction toxicity grading.
- Known sensitivity or intolerance to Oats.
- FEV1 value <80% predicted or any clinical features of moderate or persistent asthma per 2007 National Heart Lung and Blood Institute (NHLBI) guidelines.
- Exacerbation of asthma in the past year requiring hospitalization or greater than 1 emergency department (ED) visit for asthma in the past 6 months.
- Use Beta-blockers, ACE inhibitors, angiotensin receptor blocker (ARB) , or calcium channel blockers, xolair, or immunological treatments.
- Uncontrolled hypertension per JNC 7 Guidelines (BP > 145/95 seated readings on each of two or more office visits).
- Active eosinophilic gastrointestinal disease which could be exacerbated by peanut oral immunotherapy.
- Chronic diseases such as diabetes, liver, gastrointestinal, kidney, cardiovascular, pulmonary disease, blood disorders, or history of ischemic cardiovascular disease, or other conditions that in the opinion of the Investigator make the subject unsuitable for induction of food allergy reactions.
- Unable to speak English.
- Inability to discontinue antihistamines prior to food challenges and skin prick tests.
Sites / Locations
- University of North Carolina
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Open label peanut flour
Arm Description
Orally ingested peanut flour administered in gradually increasing doses up to a maximum maintenance dose.
Outcomes
Primary Outcome Measures
Determine Whether This Peanut OIT Protocol Lowers Their Risk of Anaphylactic Reactions and Causes Long-term Tolerance.
Assess mg of peanut tolerated on double-blind placebo-controlled food challenge as a measure of desensitization and tolerance
Secondary Outcome Measures
Determine the Effect That PNOIT Has on the Peanut-specific Cellular and Humoral Response in Peanut-allergic Subjects.
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
Full Information
NCT ID
NCT01274429
First Posted
January 9, 2011
Last Updated
February 27, 2018
Sponsor
University of North Carolina, Chapel Hill
1. Study Identification
Unique Protocol Identification Number
NCT01274429
Brief Title
Peanut Oral Immunotherapy (OIT) - Initial Pilot Study in Adults
Official Title
Peanut Oral Immunotherapy (OIT) - Initial Pilot Study in Adults
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Terminated
Why Stopped
Lack of funding
Study Start Date
December 2010 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The goal of this study is to produce a new treatment that would benefit adult subjects by lowering the risk of anaphylactic reactions (desensitization), and changing the peanut-specific immune response in subjects who have peanut allergy (tolerance). This project is designed to study the innovative idea that oral immunotherapy (OIT), the ingestion of small increasing amounts of food allergen, will desensitize subjects with peanut hypersensitivity by regulating their mucosal and systemic immune reactivity and cause long-term tolerance.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peanut Allergy
Keywords
Peanut allergy, Immunotherapy, OIT
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Open label peanut flour
Arm Type
Experimental
Arm Description
Orally ingested peanut flour administered in gradually increasing doses up to a maximum maintenance dose.
Intervention Type
Drug
Intervention Name(s)
Peanut flour
Other Intervention Name(s)
Peanut OIT
Intervention Description
Peanut flour that is ingested daily and administered in gradually increasing amounts up to a maximum maintenance dose.
Primary Outcome Measure Information:
Title
Determine Whether This Peanut OIT Protocol Lowers Their Risk of Anaphylactic Reactions and Causes Long-term Tolerance.
Description
Assess mg of peanut tolerated on double-blind placebo-controlled food challenge as a measure of desensitization and tolerance
Time Frame
2-3 years
Secondary Outcome Measure Information:
Title
Determine the Effect That PNOIT Has on the Peanut-specific Cellular and Humoral Response in Peanut-allergic Subjects.
Description
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
Time Frame
2-3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age 18 to 50 years of age of any gender, race, or ethnicity.
Diagnosis of peanut allergy OR convincing clinical history of peanut allergy.
Detectable serum peanut -specific Immune globin E(IgE) level (CAP-FEIA ≥ 0.35 kU/L) and a positive skin prick test (SPT) to peanut.
Participant willing to use effective method of contraception if female for the duration of the study, not pregnant or lactating, and not planning to become pregnant.
Positive reaction to ≤ 2 gm peanut protein on entry challenge.
Exclusion Criteria:
History of severe anaphylaxis to peanut per current National Cancer Institute Common Toxicity Criteria for Adverse Effects (NCI-CTCAE) allergic reaction toxicity grading.
Known sensitivity or intolerance to Oats.
FEV1 value <80% predicted or any clinical features of moderate or persistent asthma per 2007 National Heart Lung and Blood Institute (NHLBI) guidelines.
Exacerbation of asthma in the past year requiring hospitalization or greater than 1 emergency department (ED) visit for asthma in the past 6 months.
Use Beta-blockers, ACE inhibitors, angiotensin receptor blocker (ARB) , or calcium channel blockers, xolair, or immunological treatments.
Uncontrolled hypertension per JNC 7 Guidelines (BP > 145/95 seated readings on each of two or more office visits).
Active eosinophilic gastrointestinal disease which could be exacerbated by peanut oral immunotherapy.
Chronic diseases such as diabetes, liver, gastrointestinal, kidney, cardiovascular, pulmonary disease, blood disorders, or history of ischemic cardiovascular disease, or other conditions that in the opinion of the Investigator make the subject unsuitable for induction of food allergy reactions.
Unable to speak English.
Inability to discontinue antihistamines prior to food challenges and skin prick tests.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wesley Burks, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Peanut Oral Immunotherapy (OIT) - Initial Pilot Study in Adults
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