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

Primary Purpose

Peanut Allergy

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Peanut flour

About this trial

This is an interventional treatment trial for Peanut Allergy focused on measuring Food Hypersensitivity, Hypersensitivity, Immune System Diseases, Hypersensitivity, Immediate, Peanut Hypersensitivity, Food Allergy

Eligibility Criteria

3 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Children's Medical Center Dallas Food Allergy Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Peanut

Control

Arm Description

Peanut flour will be given in increasing amounts.

Subjects will be enrolled who meet the inclusion/exclusion criteria and followed as matched controls. These subjects will not receive any treatment.

Outcomes

Primary Outcome Measures

We will measure changes in the immune system on a molecular level affected by viral infections in peanut allergic children undergoing peanut OIT.

Secondary Outcome Measures

We will determine if our peanut OIT protocol lowers the risk of anaphylaxis in peanut allergic children.

Full Information

NCT ID

NCT01074840

First Posted

February 23, 2010

Last Updated

December 1, 2014

Sponsor

University of Texas Southwestern Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT01074840

Brief Title

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

Acronym

DCOIT

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2014

Overall Recruitment Status

Completed

Study Start Date

February 2010 (undefined)

Primary Completion Date

August 2014 (Actual)

Study Completion Date

August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Texas Southwestern Medical Center

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Peanut Allergy

Keywords

Food Hypersensitivity, Hypersensitivity, Immune System Diseases, Hypersensitivity, Immediate, Peanut Hypersensitivity, Food Allergy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Peanut

Arm Type

Active Comparator

Arm Description

Peanut flour will be given in increasing amounts.

Arm Title

Control

Arm Type

No Intervention

Arm Description

Subjects will be enrolled who meet the inclusion/exclusion criteria and followed as matched controls. These subjects will not receive any treatment.

Intervention Type

Other

Intervention Name(s)

Peanut flour

Intervention Description

Peanut-allergic subjects will be given peanut flour in increasing amounts.

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

We will determine if our peanut OIT protocol lowers the risk of anaphylaxis in peanut allergic children.

Time Frame

5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

3 Years

Maximum Age & Unit of Time

16 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

John A Bird, MD

Organizational Affiliation

University of Texas Southwestern Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Children's Medical Center Dallas Food Allergy Center

City

Dallas

State/Province

Texas

ZIP/Postal Code

75235

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

19577283

Citation

Jones SM, Pons L, Roberts JL, Scurlock AM, Perry TT, Kulis M, Shreffler WG, Steele P, Henry KA, Adair M, Francis JM, Durham S, Vickery BP, Zhong X, Burks AW. Clinical efficacy and immune regulation with peanut oral immunotherapy. J Allergy Clin Immunol. 2009 Aug;124(2):292-300, 300.e1-97. doi: 10.1016/j.jaci.2009.05.022. Epub 2009 Jul 3.

Results Reference

result

PubMed Identifier

19477496

Citation

Hofmann AM, Scurlock AM, Jones SM, Palmer KP, Lokhnygina Y, Steele PH, Kamilaris J, Burks AW. Safety of a peanut oral immunotherapy protocol in children with peanut allergy. J Allergy Clin Immunol. 2009 Aug;124(2):286-91, 291.e1-6. doi: 10.1016/j.jaci.2009.03.045. Epub 2009 May 27.

Results Reference

result

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

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