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Boiled Peanut Oral Immunotherapy

2019-09-20 03:46:49 | BioPortfolio

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%.

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

Conditions

Peanut Hypersensitivity

Intervention

Boiled Peanut Powder

Location

Cleveland Clinic Foundation
Cleveland
Ohio
United States
44195

Status

Enrolling by invitation

Source

The Cleveland Clinic

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-09-20T03:46:49-0400

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Medical and Biotech [MESH] Definitions

Allergic reaction to peanuts that is triggered by the immune system.

Allergic reaction to tree nuts and peanuts, including other LEGUMES, that is triggered by the immune system. It includes co-sensitization to other food (e.g., sesame seed).

Oil derived from PEANUTS.

Lectin purified from peanuts (ARACHIS HYPOGAEA). It binds to poorly differentiated cells and terminally differentiated cells and is used in cell separation techniques.

A device that delivers medication to the lungs in the form of a dry powder.

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