Status:
COMPLETED
Boiled Peanut Oral Immunotherapy
Lead Sponsor:
Alton Melton
Collaborating Sponsors:
The Cleveland Clinic
Conditions:
Peanut Hypersensitivity
Eligibility:
All Genders
1-16 years
Phase:
PHASE1
Brief Summary
Prospective Phase 1 clinical trial providing proof of concept data on boiled peanut oral immunotherapy (OIT) for the treatment of peanut allergy in children. The investigators hypothesize that the pro...
Detailed Description
Oral Immunotherapy will be administered utilizing a powder derived from boiled peanuts. Treatment will begin with an initial escalation day in which dosing is begun at 0.1 mg peanut protein and escala...
Eligibility Criteria
Inclusion
- Age 1-16 years
- History of immediate hypersensitivity reaction to peanut
- Evidence of IgE mediated peanut hypersensitivity within a 12 month period of study enrollment
- SPT with wheal/flare of at least 3 x 6 mm and/or Peanut specific IgE \>0.35 kU/L
Exclusion
- History of life threatening peanut anaphylaxis
- Asthma requiring more than medium dose ICS
- Prior participation in oral immunotherapy, sublingual immunotherapy or epicutaneous immunotherapy
- Oat allergy
- Cardiovascular Disease
- Use of beta-blockers (oral), angiotensin converting enzyme inhibitors, angiotensin receptor blockers, or calcium channel blockers
- Use of steroid medications in the following manners:
- Daily oral steroid dosing for greater than 1 month during the past year
- Burst or steroid course in the past 3 month before inclusion
- Greater than 2 bursts oral steroid courses in the past year of at least 1 week duration
- Pregnancy or lactation
- Eosinophilic Gastrointestinal Disease
- History of food protein-induced enterocolitis
- History of developmental delay or speech delay that precludes age- appropriate communication, in the opinion of the investigator
Key Trial Info
Start Date :
November 5 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 20 2021
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT04090203
Start Date
November 5 2019
End Date
May 20 2021
Last Update
September 19 2024
Active Locations (1)
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1
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195