Peanut Allergy Oral Immunotherapy Desensitization
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01601522|
Recruitment Status : Unknown
Verified April 2015 by Dr. Susan Waserman, McMaster University.
Recruitment status was: Active, not recruiting
First Posted : May 18, 2012
Last Update Posted : April 14, 2015
|Condition or disease||Intervention/treatment||Phase|
|Peanut Allergy||Procedure: Peanut protein Procedure: Oat flour||Phase 1|
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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Peanut Allergy Oral Immunotherapy Desensitization|
|Study Start Date :||February 2012|
|Estimated Primary Completion Date :||December 2015|
|Estimated Study Completion Date :||December 2016|
Experimental: Desentization dose
500 mg Peanut Protein
Procedure: Peanut protein
Other Name: Old Birginia Byrd Mill 12% Lightly Roasted Peanut Flour
Placebo Comparator: Placebo
Procedure: Oat flour
500 mg Oat flour
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01601522
|Hamilton, Ontario, Canada, L8N 3Z5|
|Principal Investigator:||Susan Waserman, ME||McMaster University|
|Principal Investigator:||Susan Waserman, MD||McMaster University|