Status:
COMPLETED
Peanut Oral Immunotherapy in Children With Peanut Allergy (Peanut Flour)
Lead Sponsor:
Baylor College of Medicine
Conditions:
Peanut Allergic Subjects
Eligibility:
All Genders
5-16 years
Phase:
PHASE1
Brief 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...
Detailed Description
This is a phase I, open label study for the initial 12 month desensitization phase of peanut oral immunotherapy and a 2 year maintenance phase. Subjects will be recruited to determine the immune respo...
Eligibility Criteria
Inclusion
- 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
- 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 drug.
- Participation in any interventional study for the treatment of food allergy in the past 12 months or while participating in this study.
- Poor control or persistent activation of atopic dermatitis.
- Diagnosis of persistent asthma as defined by NHLBI criteria and currently being treated with daily doses of inhaled corticosteroids or requiring a rescue inhaler more than 2 days per week.
- Inability to discontinue antihistamines for skin testing and Oral Food Challenges (OFCs).
- Pregnant female.
- Chronic medical condition requiring frequent use of oral steroids, chronic psychiatric illness or history of substance abuse.
- Active eosinophilic esophagitis requiring medication therapy during the past 12 months.
- Subjects with known oat or wheat allergy
- Subjects currently on the build-up phase of environmental allergy immunotherapy injections
- Live more than 175 miles away from Texas Children's Hospital located in the Medical Center.
Key Trial Info
Start Date :
July 31 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 11 2020
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT02203799
Start Date
July 31 2014
End Date
February 11 2020
Last Update
January 19 2024
Active Locations (1)
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1
Texas Children's Hospital
Houston, Texas, United States, 77030