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Peanut Allergy Oral Immunotherapy Desensitization

Study Purpose

The purpose of the study is to determine how a type of treatment for peanut allergy known as oral desensitization works in the immune system.

Recruitment Criteria

Accepts Healthy Volunteers

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

Yes
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 5 Years - 10 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Patients must be between 5 and 10 years of age.
  • - Patients will be confirmed to have peanut allergy based on a history of significant clinical symptoms within 60 minutes after the ingestion of peanut,the presence of specific IgE to peanut (a positive skin prick test to peanut, defined as a wheal 3 mm larger than that of the saline control; and a positive in vitro IgE [CAP-FEIA] result of >15 kU/L.
.
  • - Patients will also be accepted into the study if they have a clinical reaction to peanut ingestion within the past 6 months, a positive skin prick test to peanut as defined previously, and an in vitro peanut IgE (CAP-FEIA) result of 7 kU/L or greater.
  • - Subjects must be free of any clinically significant disease which may interfere with study evaluations.

Exclusion Criteria:

  • - Use of antihistamines or decongestant therapy 7 days prior to the clinic visit.
(antihistamines eg. diphenhydramine, desloratadine etc or throughout the desensitization phase of the study.
  • - Patients who had an acute allergic reaction to food other than peanut, drugs, or stinging insects one month prior to the recruitment clinic visit.
  • - Patients who have had a respiratory infection one month prior to the recruitment clinic visit.
  • - Patients with significant or uncontrolled asthma, (inhaled corticosteroids (fluticasone >500 mcg per day, ciclesonide >400 mcg per day or budesonide >800 mcg per day or the corresponding combination inhalers, oral prednisone in the preceding 1 month and FEV1 < 80% predicted).
Nasal steroids, bronchodilators and leukotriene inhibitors will be permitted. If Prednisone is taken, it must also be stopped 1 month prior to blood being drawn if possible.
  • - Patients who received allergy injections (immunotherapy) to environmental allergens at any time in the past.
Symptomatic atopic dermatitis or chronic urticaria which may interfere with ability to evaluate oral immunotherapy and /or requiring daily medication including antihistamines.
  • - Patients with problems related to compliance or following study instructions.
Inability to come to hospital every 2 weeks for dose escalation.

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.

NCT01601522
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.

Hamilton Health Sciences Corporation
Principal Investigator

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

Susan Waserman, MESusan Waserman, MD
Principal Investigator Affiliation McMaster UniversityMcMaster University
Agency Class

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

Other, Industry
Overall Status Active, not recruiting
Countries Canada
Conditions

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

Peanut Allergy
Additional Details

Allergic reactions to peanuts and tree nuts account for the majority of fatal and near fatal food allergic reactions, and the only treatment is complete avoidance of peanut. Despite avoidance, the majority of peanut allergic people will accidently ingest peanut. OIT has been shown to desensitize peanut allergic subjects (Hofmann et al. 2009). This would protect patients who have no other treatment, and may even form the basis for true tolerance to peanut in the future. To determine the dose and kinetics of peanut desensitization (clinically and immunologically) in peanut allergic individuals who undergo low and high dose OIT. To examine whether the severity of peanut allergy as determined by measurements of PAF and PAF AH (possible markers of reaction severity) correlate with the ability of patients undergoing OIT to achieve desensitization To assess quality of life in peanut allergic subjects before and after OIT

Arms & Interventions

Arms

Experimental: Desentization dose

500 mg Peanut Protein

Placebo Comparator: Placebo

Oat flour

Interventions

Procedure: - Peanut protein

500 mg

Procedure: - Oat flour

500 mg Oat flour

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

McMaster University, Hamilton, Ontario, Canada

Status

Address

McMaster University

Hamilton, Ontario, L8N 3Z5

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