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

NCT01074840 | Completed DMC

• 1 other identifier: 112009-006
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Peanut Allergy

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  5 years

Secondary Outcomes (1)

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

  5 years

Study Arms (2)

Peanut

ACTIVE COMPARATOR

Peanut flour will be given in increasing amounts.

Other: Peanut flour

Control

NO INTERVENTION

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

Interventions

Peanut flour OTHER

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

Peanut

Eligibility Criteria

• Age: 3 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

Children's Medical Center Dallas Food Allergy Center

Dallas, Texas, 75235, United States

Location

Related Publications (2)

• 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.

  PMID: 19577283 RESULT

• 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.

  PMID: 19477496 RESULT

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Nut and Peanut Hypersensitivity

Study Officials

• John A Bird, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics

Study Record Dates

• First Submitted: February 23, 2010
• First Posted: February 24, 2010
• Study Start: February 1, 2010
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: December 3, 2014

Record last verified: 2014-12

Locations

US (1)