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Boiled Peanut Oral Immunotherapy (BPOIT)

Primary Purpose

Peanut Hypersensitivity

Status

Active

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Boiled Peanut Powder

About this trial

This is an interventional treatment trial for Peanut Hypersensitivity focused on measuring Peanut, Allergy

Eligibility Criteria

1 Year - 16 Years (Child)All SexesDoes not accept 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

Sites / Locations

Cleveland Clinic Foundation

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Boiled Peanut Powder

Arm Description

Boiled Peanut Powder

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT04090203

First Posted

May 30, 2019

Last Updated

October 21, 2022

Sponsor

Alton Melton

Collaborators

The Cleveland Clinic

1. Study Identification

Unique Protocol Identification Number

NCT04090203

Brief Title

Boiled Peanut Oral Immunotherapy

Acronym

BPOIT

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

November 5, 2019 (Actual)

Primary Completion Date

May 20, 2021 (Actual)

Study Completion Date

August 20, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Alton Melton

Collaborators

The Cleveland Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Peanut Hypersensitivity

Keywords

Peanut, Allergy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Model Description

Prospective open label phase I

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Boiled Peanut Powder

Arm Type

Experimental

Arm Description

Boiled Peanut Powder

Intervention Type

Drug

Intervention Name(s)

Boiled Peanut Powder

Other Intervention Name(s)

Immunotherapy

Intervention 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. 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.

Primary Outcome Measure Information:

Title

Increase in tolerance to peanut in pediatric patients with peanut hypersensitivity.

Description

Time Frame

18 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Year

Maximum Age & Unit of Time

16 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jaclyn Bjelac, MD

Organizational Affiliation

Staff

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cleveland Clinic Foundation

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44195

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Boiled Peanut Oral Immunotherapy

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