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

NCT02203799 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2024-01-19

Study results available
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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.

Conditions

  • Peanut Allergic Subjects

Interventions

BIOLOGICAL

Peanut Oral Immunotherapy (POIT)

The peanut protein is ingested in the form of peanut flour. Peanut flour will be given in small pre-measured soufflé cups containing the amount of peanut flour that needs to be eaten for one dose. One dose will be taken per day. Dosage of the peanut flour will begin with 1.8 mg of peanut protein during the initial visit or the lowest tolerated dose on initial challenge and increased every 2 during the build-up phase until the maintenance dose of peanut protein (3900 mg) is reached.

Sponsors & Collaborators

  • Baylor College of Medicine

    lead OTHER

Principal Investigators

  • Carla M Davis, MD · Texas Children's Hospital/Baylor College of Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
5 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2020-02-11
Completion
2020-02-11

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02203799 on ClinicalTrials.gov