Clinical Trial: Peanut Allergy Oral Immunotherapy Desensitization

Study Status: Withdrawn
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Peanut Allergy Oral Immunotherapy Desensitization

Brief Summary: The purpose of the study is to determine how a type of treatment for peanut allergy known as oral desensitization works in the immune system.

Detailed Summary:

Allergic reactions to peanuts and tree nuts account for the majority of fatal and near fatal food allergic reactions, and the only treatment is complete avoidance of peanut. Despite avoidance, the majority of peanut allergic people will accidently ingest peanut. OIT has been shown to desensitize peanut allergic subjects (Hofmann et al. 2009). This would protect patients who have no other treatment, and may even form the basis for true tolerance to peanut in the future.

To determine the dose and kinetics of peanut desensitization (clinically and immunologically) in peanut allergic individuals who undergo low and high dose OIT.

To examine whether the severity of peanut allergy as determined by measurements of PAF and PAF AH (possible markers of reaction severity) correlate with the ability of patients undergoing OIT to achieve desensitization To assess quality of life in peanut allergic subjects before and after OIT


Sponsor: Hamilton Health Sciences Corporation

Current Primary Outcome: Ability to tolerate peanut [ Time Frame: 6 months ]

Patients undergoing peanut OIT will be challenged with peanut at the end with a DBPCFC to determine the change from threshold that they are able to tolerate.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Lessening of side effects compared to placebo [ Time Frame: 6 months ]
  • Immunological changes driving the desensitization/tolerance process [ Time Frame: 6 months ]

    To examine patients undergoing OIT for PAF and PAF AH to determine if these measurements of reaction severity affect the patient's ability to achieve OIT to peanut.

    To determine the immunological changes in the blood during the desensitization/tolerance process

  • Quality of life pre and post OIT will be done. [ Time Frame: 6 months ]
    Pre and post OIT.


Original Secondary Outcome: Same as current

Information By: McMaster University

Dates:
Date Received: July 27, 2011
Date Started: February 2012
Date Completion: December 2016
Last Updated: April 13, 2015
Last Verified: April 2015