Oral Peanut Immunotherapy for Peanut Allergic Patients
Completed · Early Phase 1
Conditions studied: Peanut Hypersensitivity
In brief
This is a study to determine if peanut oral immunotherapy (OIT) would desensitize or tolerize peanut allergic patients to peanuts in order prevent peanut allergic reactions.
Key facts
- Study ID
- NCT01891136
- Run by
- University of North Carolina, Chapel Hill
- People needed
- 36
- Starts
- 2004-04-01
- Expected to finish
- 2014-12-01
- Last updated by the study team
- 2015-06-25
Who can join
Age: 1 and older, up to 16. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Subjects between 1 and 16 years of age
- Diagnosed peanut allergy by either: 1) a positive prick skin test to peanut, CAP FEIA of 15 or greater and a history of significant clinical symptoms within one hour after ingestion of peanuts or 2) a positive prick skin test to peanut, CAP FEIA of ≥ 7 and a history of a clinical reaction to peanut ingestion within the past 6 months.
- A family that will be able to be compliant with all study visits.
You may not qualify if…
- Subjects with a history of severe anaphylaxis to peanut
- Subjects with a medical history that would prevent a DBPCFC/OFC to peanut The medical history that would prevent the DBPCFC to peanut would be a prior history of an open peanut challenge in which the patient experienced hypotension which required fluid resuscitation, respiratory compromise which necessitated ventilatory support, or poorly controlled asthma as evidenced by an forced expiratory volume in 1 second (FEV1) < 80% of predicted, or FEV1/FVC (forced vital capacity) < 75%, with or without controller medications
- Subjects unable to cooperate with challenge procedures or unable to be reached by telephone for follow-up
- Pregnant or lactating
- Allergy to oat
Where it is running
- UNC Chapel Hill — Chapel Hill, North Carolina, United States
Full record on ClinicalTrials.gov
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