Boiled Peanut Oral Immunotherapy

• Status: Enrolling by invitation
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

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 proportion of subjects successfully desensitized with boiled peanut OIT is greater than the theoretical placebo rate of 20%.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alton Melton; The Cleveland Clinic
• Collaborator: The Cleveland Clinic
• Treatments: Immunologic Factors

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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