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Peanut Oral Immunotherapy in Children With Peanut Allergy (PeanutFlour)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02203799
Recruitment Status : Completed
First Posted : July 30, 2014
Last Update Posted : July 22, 2020
Sponsor:
Information provided by (Responsible Party):
Carla McGuire Davis, Baylor College of Medicine

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 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.


Condition or disease Intervention/treatment Phase
Peanut Allergic Subjects Biological: Peanut Oral Immunotherapy (POIT) Phase 1

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 response during the administration of peanut OIT after the development of disease. Cohort will include children age 5-16 years who have peanut allergy. The study will require approximately 36 visits with 3 phases: screening phase (~ 2 months); build-up phase (weeks 1 year), followed by the maintenance phase (2 years).

The primary objective of the OIT protocol is to desensitize subjects to peanut and this occurs over the first 12 months of the study (build-up phase). The first dose will be based on the amount at which the subject reacted during a double blind placebo controlled food challenge (DBPCFC). Thereafter, dose escalation would continue as outlined in the protocol for approximately 50 weeks until the maintenance dose of peanut protein (3900 mg) is reached.

The maintenance phase will continue from the end of the build-up phase until approximately 24 months. During this phase, the subject will switch to a peanut equivalent dose for the maintenance phase. At the conclusion of the maintenance phase a DBPCFC will be done. Negative challenges will be confirmed by open challenge. DBPCFC will be done.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Immune Responses in Peanut Allergic Subjects Undergoing Peanut Oral Immunotherapy
Actual Study Start Date : July 31, 2014
Actual Primary Completion Date : February 11, 2020
Actual Study Completion Date : February 11, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Arm Intervention/treatment
Experimental: Peanut Oral Immunotherapy (POIT)
The peanut OIT is taken in the form of peanut flour. It will be given in small cups containing the amount of flour that needs to be eaten for one dose. One dose should be taken per day.
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.
Other Names:
  • Peanut Flour
  • Peanut Oral Immunotherapy




Primary Outcome Measures :
  1. Safety and Efficacy [ Time Frame: 3 years ]
    Determine whether peanut oral immunotherapy safely develops clinical tolerance in peanut allergic subjects by assessing the change of dose tolerated and to determine the percentage of subjects who can tolerate 6 g of peanut flour with absence of clinical symptoms during a food challenge following the initial desensitization phase of peanut flour


Secondary Outcome Measures :
  1. Immune Response [ Time Frame: 3 years ]
    To determine the immune mechanisms of clinical tolerance, using technology to identify T cell cytokine responses and subsets, as well as basophil activation responses as measured by flow cytometry. T and NKT cell function and intracellular cytokine expression will be measured.

  2. Viral Exposure [ Time Frame: 3 years ]
    To determine whether viral exposure potentiates response to in vitro peanut allergen exposure and to assess those changes during peanut OIT.

  3. Dose Toleration [ Time Frame: 3 years ]
    To compare the change in dose tolerated after one month of abstaining from peanut to determine sustained unresponsiveness.



Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02203799


Locations
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United States, Texas
Texas Children's Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine
Investigators
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Principal Investigator: Carla M Davis, MD Texas Children's Hospital/Baylor College of Medicine
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Responsible Party: Carla McGuire Davis, Associate Professor, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT02203799    
Other Study ID Numbers: 26819
First Posted: July 30, 2014    Key Record Dates
Last Update Posted: July 22, 2020
Last Verified: July 2020
Keywords provided by Carla McGuire Davis, Baylor College of Medicine:
Peanut Allergy
Anaphylaxis
Desensitization
Food Allergy
Oral Immunotherapy
Additional relevant MeSH terms:
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Peanut Hypersensitivity
Nut and Peanut Hypersensitivity
Food Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Immunologic Factors
Physiological Effects of Drugs