Boiled Peanut Oral Immunotherapy

NCT ID: NCT04090203

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-05
• Study Completion Date: 2021-05-20

Brief 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%.

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.

Conditions

Peanut Hypersensitivity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Boiled Peanut Powder

Boiled Peanut Powder

Group Type: EXPERIMENTAL

Boiled Peanut Powder

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Immunotherapy

Eligibility 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

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Cleveland Clinic

OTHER

Sponsor Role: collaborator

Alton Melton

OTHER

Sponsor Role: lead

Responsible Party

Alton Melton

Sponsor-Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Jaclyn Bjelac, MD

Role: PRINCIPAL_INVESTIGATOR

Staff

Locations

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

BPOIT 18-1294

Identifier Type: -

Identifier Source: org_study_id