Support Our Food Allergy Research. Donate Now!
The incidence of food allergy has dramatically increased in the United States within the last 20 years. Throughout the country, research is being done on what could be causing these food allergies, as well as how we can treat them. At our Food Allergy Center, research is being conducted in both of these areas.
Clinical Trials
Multiple clinical trials are being conducted looking at possible treatments for food allergy to decrease the chance or severity of an allergic reaction when accidentally ingested. Immunotherapy is currently the main focus of research in food allergy clinical trials, which involves exposing the patient to very small amounts of the food that they are allergic to, in hopes that their immune system will stop reacting to it. This therapy is done under close physician supervision using a strict protocol due to the risk of side effects. These treatments are not safe to be tried at home.
Clinical trials at our Food Allergy Center include oral immunotherapy, given by mouth, and epicutaneous immunotherapy, given through a patch on the skin. We are currently involved in clinical trials for peanut allergyand milk allergy.
Active (currently recruiting)
Principal Investigator: Dr. Stephanie Leonard
This study is looking at whether giving an investigational therapeutic probiotic to infants may help to prevent allergic diseases. We are recruiting pregnant women in their 3rd trimester. Participants are compensated. Please contact Beth Kiernan, CRC, at ekiernan@rchsd.org for more information. ClinicalTrials.gov Identifier: NCT05003804.
Using Biologics to Improve Multi Oral Immunotherapy (mOIT) Outcomes (COMBINE Study)
Principal Investigator: Dr. Stephanie Leonard
In this study, we will treat participants with oral immunotherapy to two or three different foods (one of which must be peanut) and biologics. This is a study designed to determine if using biologics (omalizumab and dupilumab) and multi oral immunotherapy (mOIT) will increase tolerance to multiple food allergens. If you or your child is between 4-25 years old and is allergic to peanut and at least one of the following — almond, cashew, hazelnut, egg, walnut, sesame seed, soy, shellfish, fish, wheat or milk — then you/they may be eligible to participate. Please contact Amy Grissinger, CPNP, at agrissinger@rchsd.org for more information. ClinicalTrials.gov Identifier: NCT03679676.
Ongoing (recruitment closed)
Peanut Allergy Patch Trial in Young Children (EPITOPE)
Principal Investigator: Dr. Stephanie Leonard
This is a study designed to determine if an investigational skin patch is safe and effective when used as epicutaneous immunotherapy for peanut allergy in young children aged 1-3 years old. https://clinicaltrials.gov/ct2/show/NCT03211247
Peanut Oral Immunotherapy Trial (ARC008)
Principal Investigator: Dr. Stephanie Leonard
This is a study investigating AR101 oral immunotherapy as a treatment for peanut allergy.
https://clinicaltrials.gov/ct2/show/NCT03292484
Peanut Allergy Patch Study (PEOPLE)
Principal Investigator: Dr. Stephanie Leonard
This is a study designed to determine if an investigational skin patch is safe and effective when used as epicutaneous immunotherapy for peanut allergy in children between the ages 4-11 years old. https://clinicaltrials.gov/ct2/show/NCT03013517
Milk Allergy Patch Study (MILES)
Principal Investigator: Dr. Stephanie Leonard
This a study designed to determine if an investigational skin patch is safe and effective when used as epicutaneous immunotherapy for milk allergy. https://clinicaltrials.gov/ct2/show/NCT02223182
Clinical Research
If you are interested in supporting novel food allergy research at Rady Children’s Hospital, please contact Rady Children’s Hospital Foundation.
San Diego Food Allergy Registry
Principal Investigator: Dr. Stephanie Leonard
This registry collects clinical, laboratory and genetic data to study the development of and natural history of food allergy in children. For those children in the Food Allergy Registry, extra blood from regular laboratory testing is collected and studied for research purposes. De-identified (i.e. without patient personal information) clinical and laboratory information may also be used in collaboration with other scientists and national leaders performing food allergy research. The hope is that we will learn about who develops food allergies and who is likely to outgrow them in order to help patients now and in the future.
Baked Egg and Milk Study
Principal Investigators: Drs. Susan Laubach and Stephanie Leonard
About 70% of milk- and egg-allergic children are able to tolerate baked forms of milk and egg, such as in a muffin, due to denaturation of the proteins by heat and interactions with a food matrix. Studies have indicated that children who are able to include baked milk and egg products in their diets are more likely to outgrow their allergy. These findings indicate that baked milk and egg may act as a form of immunotherapy. The main purpose of our study is to investigate if the addition of progressively less-baked milk and egg will help patients outgrow their milk or egg allergy sooner. In collaboration with Dr. Bjoern Peters laboratory at La Jolla Institute Immunology, we are also studying the ability of standard allergy testing and mechanistic studies to predict clinical reactivity to baked milk and egg, as well as persistence of allergy. See Abstract. See Article.
Fish Allergy Study
Principal Investigator: Dr. Stephanie Leonard
Research is to be conducted into the cross-reactivity between different fish species using laboratory testing and selected oral food challenges. Children with known fish allergy may be challenged to different fish species to see if they are able to tolerate some species despite being allergic to others. The hope is to be able to expand their diet to include some types of fish while avoiding others and learn more about fish allergy. See Abstract.
To find out more information about these studies and possible involvement, please contact Amy Grissinger, CPNP, at agrissinger@rchsd.org.
