Peanut Oral Immunotherapy in Children With Peanut Allergy (PeanutFlour)
|ClinicalTrials.gov Identifier: NCT02203799|
Recruitment Status : Completed
First Posted : July 30, 2014
Last Update Posted : July 22, 2020
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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||27 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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
- 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.
- 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.
- Dose Toleration [ Time Frame: 3 years ]To compare the change in dose tolerated after one month of abstaining from peanut to determine sustained unresponsiveness.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02203799
|United States, Texas|
|Texas Children's Hospital|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Carla M Davis, MD||Texas Children's Hospital/Baylor College of Medicine|