Boiled Peanut Oral Immunotherapy (BPOIT)

Alton Melton

Status and phase

Completed

Phase 1

Conditions

Peanut Hypersensitivity

Treatments

Drug: Boiled Peanut Powder

Study type

Interventional

Funder types

Other

Identifiers

NCT04090203

BPOIT 18-1294

Details and patient eligibility

About

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%.

Full 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 escalated to a final dose of 6 mg peanut protein. Doses are ingested orally. Participants will continue daily oral ingestion of doses at home and return for updosing every 2 weeks to a final maintenance dose of 300 mg peanut protein. Participants will continue daily oral ingestion of the peanut product for a minimum duration of 28 days before undergoing exit double blind placebo controlled food challenge. At the conclusion of the study, participants will be offered continued maintenance therapy off study in line with current specialty standards.

Enrollment

8 patients

Sex

All

Ages

1 to 16 years old

Volunteers

No Healthy Volunteers

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