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Boiled Peanut Oral Immunotherapy — BPOIT  

Peanut Hypersensitivity Clinical Trial

Official title:
Boiled Peanut Oral Immunotherapy for the Treatment of Peanut Allergic Pediatric Patients

Clinical Trial 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%.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04090203
Study type Interventional
Source The Cleveland Clinic
Contact
Status Active, not recruiting
Phase Phase 1
Start date November 5, 2019
Completion date August 20, 2023
View Details
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