Understanding How the Immune System Responds to Viruses in Peanut Allergic Children Undergoing Peanut Oral Immunotherapy (DCOIT)

December 1, 2014 updated by: Drew Bird, University of Texas Southwestern Medical Center

Dendritic Cell Responses to Viral Stimulation in Peanut Allergic Subjects Undergoing Peanut Oral Immunotherapy

The purpose of this study is to find out if there is a way to treat children with peanut allergy to help lower the risk of severe allergic reactions and also cause them to lose their allergy to peanuts and to understand what happens to their immune systems when they have viral infections while on therapy. The approach we will use to treat peanut allergy in this study is a process called desensitization.

We think that children with a peanut allergy receiving peanut oral immunotherapy will be able to eat more peanuts without having a reaction by the end of the study than they could eat at the beginning. We also think that we will be able to measure changes in their immune system and their immune system's response to viruses while they are on therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Peanut allergy is known to cause severe anaphylactic reactions. Compared with other food allergies it tends to be more persistent and also its prevalence seems to be rising. Currently there is no proven treatment other than strict avoidance. We are attempting to decrease the risk of anaphylaxis on accidental ingestion by desensitizing subjects to peanut using peanut oral immunotherapy (OIT). We are also studying the effect of viral infections on the immune system in children receiving peanut OIT.

Children ages three to sixteen years of age with peanut allergy will be given peanut OIT. Twenty-five subjects will also be recruited as controls. These subjects will not receive any peanut or placebo but only have skin prick testing and lab work in addition to a history and physical exam. Active subjects will undergo a double-blind food challenge at entry to verify that they are allergic to peanuts. If allergic, they will then have modified rush immunotherapy on the first day and then increase the doses at least every two weeks up to a maintenance dose of 4 grams (equivalent to about 13 peanuts). Doses will be taken daily at home except for dose increases which will be done at Children's Medical Center. Outcome variables of interest include response to double-blind placebo controlled food challenge, skin prick testing, peanut specific IgE, and adverse events. These results will be compared between the start and end of peanut OIT using appropriate statistical analysis.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75235
        • Children's Medical Center Dallas Food Allergy Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 3 to 16 years of either sex, any race, any ethnicity, weighing at least 18.3 kg at the time of the initial visit.
  • The presence of IgE specific to peanuts (a positive skin prick test to peanuts (diameter of wheal > 3.0 mm) and a positive in vitro IgE (CAP-FEIA) > 7 kU/L) measured within the past year.
  • Significant clinical symptoms occurring within 60 minutes after ingesting peanuts during an observed Double-Blind Placebo Controlled Food Challenge.
  • Provide signed informed consent.
  • Ability to follow-up regularly for scheduled appointments.
  • Females of child-bearing potential must be willing to practice an acceptable form of birth control throughout the protocol.

Exclusion Criteria:

  • History of severe anaphylaxis to peanut as defined by hypoxia, hypotension, or neurological compromise (Cyanosis or SpO2 < 92% at any stage, hypotension, confusion, collapse, loss of consciousness; or incontinence)
  • Currently participating in a study using an investigational new drug.
  • Participation in any interventional study for the treatment of food allergy in the past 12 months or while participating in this study.
  • Subjects with a known oat or wheat (because of potential cross contamination with oat) food allergy will be excluded
  • Poor control or persistent activation of atopic dermatitis.
  • Diagnosis of asthma and currently being treated with daily doses of inhaled corticosteroids or requiring a rescue inhaler more than 2 days per week.
  • Inability to discontinue antihistamines for skin testing and Oral Food Challenges (OFCs).
  • Pregnant female.
  • Chronic medical condition requiring frequent use of oral steroids, chronic psychiatric illness or history of substance abuse.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Peanut
Peanut flour will be given in increasing amounts.
Other: Peanut flour
Peanut-allergic subjects will be given peanut flour in increasing amounts.
No Intervention: Control
Subjects will be enrolled who meet the inclusion/exclusion criteria and followed as matched controls. These subjects will not receive any treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
We will measure changes in the immune system on a molecular level affected by viral infections in peanut allergic children undergoing peanut OIT.
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
We will determine if our peanut OIT protocol lowers the risk of anaphylaxis in peanut allergic children.
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Texas Southwestern Medical Center

Investigators

  • Principal Investigator: John A Bird, MD, University of Texas Southwestern Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

February 23, 2010

First Submitted That Met QC Criteria

February 23, 2010

First Posted (Estimate)

February 24, 2010

Study Record Updates

Last Update Posted (Estimate)

December 3, 2014

Last Update Submitted That Met QC Criteria

December 1, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 112009-006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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