CompletedPhase 1

Peanut Oral Immunotherapy in Children With Peanut Allergy (Peanut Flour)

United States15 participantsStarted 2014-07-31

Plain-language summary

Many children who are allergic to peanuts do not outgrow their allergy and have very severe allergic reactions called anaphylaxis. Symptoms of anaphylaxis include difficulty breathing, decreased blood pressure, hives, and lip or throat swelling after exposure to an allergen. A severe allergic reaction can lead to death if not treated appropriately. The purpose of this study is to find out if there is a way to treat children with peanut allergy to help lower the risk of severe allergic reactions and also cause them to lose their allergy to peanuts. The approach that will used for this study is a process called "desensitization". Oral immunotherapy involves eating gradually increasing amounts of a food over several months. This is a research study because at this time peanut oral immunotherapy (OIT) is investigational. Peanut OIT (study drug) is investigational because it is not currently approved for clinical use by the Food and Drug Administration. There are no alternative safe and effective treatments for peanut induced allergic reactions other than peanut avoidance and treatment with medications.

Who can participate

Age range5 Years – 16 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age 5-16 years of either sex, any race, any ethnicity, weighing at least 18.3 kg at the time of the initial visit. * The presence of Immunoglobulin E (IgE) specific to peanuts (a positive skin prick test to peanuts (diameter of wheal \> 3.0 mm) and a positive in vitro IgE \[CAP-FEIA\] \> 7 kUA/L) measured within the past year. * Significant clinical symptoms occurring within 120 minutes after ingesting peanuts during an observed DBPCFC. Patients who have not had previous oral exposure to peanut will be observed for a longer duration of 150 minutes because they may demonstrate a delayed immune response, given the lack of prior peanut exposure. Also, patients with a history of prior anaphylaxis will be observed for 150 minutes. * Provide signed informed consent. * Ability to follow-up regularly for scheduled appointments. * Subjects will not be excluded if they are primarily Spanish speaking. * Females of childbearing potential must be willing to practice an acceptable form of birth control throughout the protocol. * Epinephrine injection training provided. Participant has current in-date epinephrine injector and parent/guardian demonstrates proper use Exclusion Criteria: * History of severe anaphylaxis to peanut as defined by hypoxia, hypotension, or neurological compromise (Cyanosis or SpO2 \< 92% at any stage, hypotension, confusion, collapse, loss of consciousness; or incontinence) * Currently participating in a study using an investigational new dr…

What they're measuring

Determine the Percentage of Patients Tolerating the 12-month DBPCFC

Timeframe: Month 12 after first dose of peanut flour

Trial details

NCT IDNCT02203799

SponsorBaylor College of Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-02-11

Results submitted2021-05-05