Suspended
WOITWalnut Oral Immunotherapy for Tree Nut Allergy
What is being tested
Walnut Protein Flour
+ Oat flour
Drug
Who is being recruted
Nut and Peanut Hypersensitivity+3
+ Food Hypersensitivity
+ Hypersensitivity
From 6 to 45 Years
+17 Eligibility Criteria
How is the trial designed
Treatment Study
Placebo-ControlledPhase 1 & 2
Interventional
Study Start: November 2013
Summary
Principal SponsorUniversity of North Carolina, Chapel Hill
Last updated: June 17, 2016
Sourced from a government-validated database.Claim as a partner
Study start date: November 1, 2013
Actual date on which the first participant was enrolled.Tree nut
Principal SponsorUniversity of North Carolina, Chapel Hill
Last updated: June 17, 2016
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 6 to 45 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Nut and Peanut HypersensitivityFood HypersensitivityHypersensitivityHypersensitivity, ImmediateImmune System DiseasesNut Hypersensitivity
Criteria
5 inclusion criteria required to participate
A positive 2000 mg oral food challenge at enrollment to walnut and to one other tree nut
Age 6 to 45 years, either sex, any race, any ethnicity with a convincing clinical history of walnut or another tree nut allergy and either a positive prick skin test ( > 3mm) or serologic evidence of allergic sensitization (defined as specific IgE > 0.35 kU/L) to walnut and at least one other tree nut
All females of child bearing age must be using appropriate birth control
Written assent from all subjects as appropriate
Show More Criteria
12 exclusion criteria prevent from participating
Active eosinophilic or other inflammatory (e.g., celiac) gastrointestinal disease in the past 2 years
Chronic disease (other than asthma, atopic dermatitis, rhinitis) requiring therapy or other respiratory or medical conditions deemed by the investigator to put the subject at increased risk of anaphylaxis or poor outcomes from receiving OIT or undergoing food challenge
History of severe anaphylaxis to walnut or other tree nuts, defined as symptoms associated with hypoxia, hypotension or neurologic compromise (cyanosis or SpO2 < 92% at any stage, hypotension, confusion, collapse, loss of consciousness; or incontinence)
Inability to discontinue antihistamines for initial day escalation, skin testing or OFC
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
Active ComparatorWalnut protein flour that is ingested in gradually increasing amounts up to a maintenance dose.
Group II
PlaceboOat flour administered in identical increasing amounts as the active walnut protein flour.
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has no location dataSave this study to your profile to know when the location data is available.
SuspendedNo study centers