Boiled Peanut Oral Immunotherapy (BPOIT)

Boiled Peanut Oral Immunotherapy for the Treatment of Peanut Allergic Pediatric Patients

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%.

Study Overview

• Status: Active, not recruiting
• Conditions: Peanut Hypersensitivity
• Intervention / Treatment: Drug: Boiled Peanut Powder

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 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 Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 16 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Boiled Peanut Powder

Drug: Boiled Peanut Powder; 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. The subjects 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. The subjects will continue daily oral ingestion of the peanut product for a minimum duration of 28 days before undergoing exit DBPCFC. At the conclusion of the study, patients will be offered continued maintenance therapy off study in line with current specialty standards.; Other Names: Immunotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Increase in tolerance to peanut in pediatric patients with peanut hypersensitivity.	The investigator will compare the proportion of patients successfully desensitized as defined by meeting the primary endpoint with the expected placebo rate. The null hypothesis is that the proportion of patients successfully desensitized by boiled peanut oral immunotherapy will not be greater than the expected 20% that has been previously published as the proportion of patients successfully meeting the primary endpoint in OIT studies (which aligns with the expected 20% that would naturally "outgrow" a peanut allergy). If the null hypothesis is rejected, it can be concluded that the proportion of patients successfully desensitized by boiled peanut therapy is greater than placebo.	18 weeks

Collaborators and Investigators

• Sponsor: Alton Melton
• Collaborators: The Cleveland Clinic
• Investigators: Principal Investigator: Jaclyn Bjelac, MD, staff

Study record dates

Study Major Dates

• Study Start (Actual): November 5, 2019
• Primary Completion (Actual): May 20, 2021
• Study Completion (Anticipated): August 20, 2023

Study Registration Dates

• First Submitted: May 30, 2019
• First Submitted That Met QC Criteria: September 12, 2019
• First Posted (Actual): September 16, 2019

Study Record Updates

• Last Update Posted (Actual): October 24, 2022
• Last Update Submitted That Met QC Criteria: October 21, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Allergy; Peanut
• Additional Relevant MeSH Terms: Immune System Diseases; Food Hypersensitivity; Hypersensitivity, Immediate; Nut and Peanut Hypersensitivity; Hypersensitivity; Peanut Hypersensitivity
• Other Study ID Numbers: BPOIT 18-1294

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No