McMaster University
Hamilton, Ontario, L8N 3Z5, Canada
NCT Number: NCT01601522
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.
Objectives
1. To determine whether premedication with desloratidine and ranitidine results in fewer side effects during desensitization procedure. 2. To assess quality of life in peanut allergic subjects before and after desensitization. 3. To compare serum metabolites in peanut allergic and non peanut allergic subjects.
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Notify Me5 year–10 year
All sexes
Interventional
Phase 2
Hamilton, Ontario, L8N 3Z5, Canada
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.
Objectives:
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
500 mg
Other names: Old Birginia Byrd Mill 12% Lightly Roasted Peanut Flour
500 mg Oat flour
Desloratidine 5 ml po od (0.5mg/ml = 2.5 mg) Ranitidine 5ml (15mg/ml=75 mg) po bid
Other names: Desloratadine and Ranitidine
Time frame: 6-12 months
Frequency and risk of adverse events, overall and stratified by organ system and severity
Time frame: 6-12 months
Pre and post OIT.
Time frame: 6-12 months
Patients will be challenged at the end of the treatment period with peanut at the end to determine the change from threshold that they are able to tolerate.
Time frame: 6-12 months
Various mechanistic outcomes/biomarkers
Hamilton Health Sciences Corporation
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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