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Boiled Peanut Oral Immunotherapy

Study Purpose

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%.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 1 Year - 16 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04090203
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Alton Melton
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Jaclyn Bjelac, MD
Principal Investigator Affiliation Staff
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

OtherOther
Overall Status Enrolling by invitation
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Peanut Hypersensitivity
Additional Details

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.

Arms & Interventions

Arms

Experimental: Boiled Peanut Powder

Boiled Peanut Powder

Interventions

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.

Contact a Trial Team

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Cleveland Clinic Foundation, Cleveland, Ohio

Status

Address

Cleveland Clinic Foundation

Cleveland, Ohio, 44195

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