Clinical research studies health and illnesses in people. Experts use research to study the causes of diseases and symptoms, as well as if treatments or other procedures work. They also look for medical approaches to prevent, detect, or treat diseases and illnesses. Clinical research studies are important to help advance treatments for asthma and allergic diseases.
The Food Allergy Research Section (FARS) at the National Institutes of Health (NIH) is a research program dedicated to studying food allergy and other related diseases. FARS is currently working on clinical studies around food allergy, eczema, and nutrition. Sanaz Eftekhari, Chief Business Development Office and Vice President of Research for the Asthma and Allergy Foundation of America (AAFA), sat down with the FARS team to discuss what they do, their current studies, and how people can get involved.
In the following video, you’ll also hear from:
- Pamela A. Guerrerio, MD, PhD
Chief, Food Allergy Research Section
Chief, Laboratory of Allergic Diseases, National Institute of Allergy and Infectious Diseases (NIAID), NIH
- Fernanda D. Young, MD
Assistant Research Physician, Food Allergy Research Section
Laboratory of Allergic Diseases, NIAID, NIH
- Ozge N. Aktas, MD
Fellow Physician, Food Allergy Research Section
Laboratory of Allergic Diseases, NIAID, NIH
- Joanna M. Utoh, CRNP, MSN
Family Nurse Practitioner, Food Allergy Research Section
Laboratory of Allergic Diseases, NIAID, NIH
- Ellen Zektser, RN, BSN, MPH
Research Specialist Nurse, Food Allergy Research Section
Laboratory of Allergic Diseases, NIAID, NIH
Sanaz Eftekhari, AAFA (SE): My name is Sanaz. I'm with the Asthma and Allergy Foundation of America, and I'm the Vice President for Research. I'm really excited to be here with the Food Allergy Research Section from the National Institutes of Allergy and Infectious Diseases. Dr. Guerrerio, if you can, kick us off with introductions.
Dr. Pam Guerrerio (PG): Hi. My name is Pam Guerrerio. I am Chief of the Food Allergy Research Section in NIAID at the National Institutes of Health. I am a pediatrician and board certified in allergy and immunology.
Dr. Fernanda Young (FY): My name is Fernanda Young, and I am a clinician and research physician with the Food Allergy Research Section. I see patients who undergo food allergy evaluation with skin testing, lab work, and the gold standard test, which is a placebo-controlled food challenge.
Dr. Ozge Aktas (OA): My name is Ozge Aktas, and I'm a clinical fellow in the Food Allergy Research Section at NIAID. I'm currently in the second year of my training to become a board-certified allergist immunologist and participating in food allergy research in Dr. Guerrerio's lab.
Joanna Utoh (JU): My name is Joanna Utoh, and I'm a family nurse practitioner. I've been working with the Food Allergy Research Section for almost three years, I’m one of the providers who evaluates and treats our patients with food allergies and other allergic conditions. I really enjoy working with families to provide eczema education, management, and ongoing support to help patients get their eczema under control when needed.
Ellen Zektser (EZ): Hi, my name is Ellen Zektser, and I'm the research specialist nurse for the team. I coordinate all of our study activities and assist in the oral food challenges. I would typically be the participants’ first contact and will perform screening to determine eligibility. I work with the participants to accomplish all of the logistics, including scheduling, outside record review, registration, and coordination of all of the various entities that support our oral food challenges.
SE: We're really excited to talk to you about the Food Allergy Research Section overall and then maybe some of the specific studies that you guys are working on right now. I know a lot of people have heard of NIH, and they may have heard of the National Institute of Allergy and Infectious Diseases, but they may not be aware of the types of research that you do or even that you may see patients. So, could you tell us a little bit about what your team does in our space?
PM: The Clinical Center at the NIH is actually the largest research hospital in the world, entirely devoted to clinical research. We do different types of clinical studies. Some studies are what we call natural history studies, where we follow patients for a long period of time to see how their disease evolves. Other types of studies are aimed more at finding new treatments or interventional studies to try and improve how we take care of those patients.
My protocols are mostly focused on people with food allergy and related diseases such as eczema and eosinophilic esophagitis. And our goal is really to try and find better ways for diagnosing those conditions, improving the care of those patients, and eventually finding cures for those diseases.
SE: Can you just tell us a little bit about the NIH Food Allergy Research Section and what your goals are?
PM: The Food Allergy Research Section consists of a team of doctors, nurses, nurse practitioner, and scientists who are working together to improve the lives of people with food allergy. Our goal is to better understand what causes food allergy, why this disease has become so much more common in recent years, and ultimately to find a cure. While we are working toward a cure, we are developing better strategies to diagnose food allergy, as well as to improve the care and overall treatment of these patients.
SE: And Dr. Young, I know that Dr. Guerrerio gave us an overview of the Food Allergy Research Section, but can you tell us a little bit about why researching food allergy and eczema is really important for the NIH overall?
FY: Absolutely. As you've probably just seen in your day-to-day life, eczema and food allergy have become really common problems, particularly among children in the U.S. Food allergy is estimated to affect about one out of every 16 children, so definitely a couple in a classroom. And eczema affects about one out of every three Americans. So we do know that eczema is an important risk factor for food allergy. Just about a third of people who have eczema will go on to develop a food allergy. And both food allergy and eczema can profoundly reduce the quality of life for the patient and their caregivers, especially when the patient has a reaction. Because food allergy can result in severe and life-threatening reactions, the NIH wants to better understand this connection between eczema and food allergy and really find ways to improve prevention and treatment of both eczema and food allergy.
SE: And we know from working with people in our community over at the Asthma and Allergy Foundation of America that there's a lot of overlap, too, either within the same person living with food allergies and eczema or within the family. Joanna, can you tell us a little bit about the purpose of the NIH’s current research on food allergy and eczema?
JU: Yes. We know that both genetics and the environment contribute to the development of allergic disease. We have a number of ongoing studies designed to understand how these two factors work together to affect a child's risk of developing allergic disease. We're also working to find better ways of diagnosing food allergy, particularly among children with eczema who often test positive for food allergies even when they're not truly allergic, which can lead to unnecessary food avoidance. And finally, we want to understand how nutrition and bone health are affected in children with food allergy and how this is affected by the type and the number of food allergies that they may have, as well as the presence of other allergic conditions, in particular eczema.
SE: Dr. Aktas, moving over to you. Talk to us a little bit about why researching food allergy and nutrition is important for the NIH.
OA: Absolutely. Most major food allergens, as you might all be very aware, including milk, egg, wheat, and peanut, are nutritionally dense and staple foods in our diet. So, children avoiding these foods can have a variety of nutritional deficiencies that could affect their growth and overall health, including their bone health. Previous studies have shown that children with milk allergy are at higher risk for low bone density. But we do not know if this is true in children with other types of food allergies or children with other allergic diseases, including eczema. We also don't know the long-term consequences of food avoidance on their risk of fractures and overall nutrition and growth, so with our studies at NIH, we hope to provide some insight into these questions.
SE: Dr. Guerrerio, can you tell us a little bit about who can participate in these studies for food allergy and eczema?
PG: Participation in our food allergy study is open to both adults and children who are at least two years of age, who have an IgE-mediated food allergy. This includes people both who have had an allergic reaction to the food, as well as those who have been told to strictly avoid a food because of positive testing. Participation in our eczema study is open to individuals between the ages of 3 and 21 years who either currently have eczema or a history of eczema, along with positive IgE testing to milk or peanut regardless of whether they can eat those foods or not.
SE: Is there anything that would exclude somebody from participating in a study?
EZ: Sure. Pregnancy and those diagnosed with a genetic disease would be excluded from participating. Additionally, there are certain medications such as DUPIXENT®, which would prevent someone from participating at this time.
SE: And how much time generally does it take to participate in one of those two studies?
PG: Participants should expect to spend about a half day at our NIH campus in Bethesda, Maryland, for their initial visit. Once we receive all their test results back, then there is a second shorter visit where we review the results and discuss our recommendations. After this initial consultation, participants are able to come back to NIH about every year or every other year for follow up visits.
SE: Dr. Aktas, does that mean that participation requires travel, and if so, how many visits?
OA: We can schedule a virtual visit where the participant will be consented to the study, and one of our providers will obtain a detailed history. Shortly after that virtual visit, the participant will be seen at the Clinical Center in person. The participant will not have to travel to the NIH more frequently than once a year.
SE: What can people expect at that initial appointment?
JU: Participants will have bloodwork, skin prick testing, and a physical exam at the first appointment. Depending on the participants’ needs, they may also have a bone density scan and additional nutritional labs to help evaluate the nutritional impact of allergy related food avoidances. In particular, participants will meet with a dietician and we check for a number of micro and macronutrients like iron, B-12, and other vitamins so we can see if there are any deficiencies. We then provide recommendations to help optimize each participant's nutritional intake and their growth. And at that first visit, and while you're on study, we’ll continue to prescribe medications for most severe allergic conditions. That includes EpiPens® and eczema creams.
SE: And Dr. Young, we heard a little bit about the eligibility criteria, but can you tell us who can sign up in the United States in terms of where they live or if they have to be in the U.S.?
FY: That's a great question. Since we are the National Institutes of Health, we want to make sure that we represent the nation as a whole. And so as you heard from the inclusion and exclusion criteria from Dr. Guerrerio, we really didn't mention any zip codes or states. It's really meant to be a representation of the nation. So as long as a patient or participant meets the eligibility criteria, then they are able to sign up for our study.
SE: Just to talk a little bit about logistics, are the travel costs covered for participants? If once they get through the virtual visit, they do need to travel to Bethesda to the NIH?
EZ: Typically the first visit is covered by the participant and all subsequent travel costs will be covered by the NIH. However, if traveling to the NIH for a first-time visit proves to be a financial burden, then we can initiate a financial assessment and can potentially offer some financial support.
SE: And I think AAFA is available as well to help connect people with resources if they do need help covering those travel costs. So, Ellen, what about insurance? Do participants need to be on any sort of insurance?
EZ: No, insurance is not required to participate, nor is it required for the medications that may be prescribed at your appointment. One of the great things about receiving care at the NIH is that all care provided at the NIH is provided at no charge to the participant or to their insurance.
SE: And that's really a great benefit. If they are chosen to participate in the study and may need to travel or take time off work, are participants compensated for their time?
EZ: Participants will be compensated if research labs are collected.
SE: Ellen, what about people who want to participate whose first language may not be English or they may not be comfortable speaking about medical or health-related things in English? Does the NIH offer any sort of other language services or accessibility for these studies?
EZ: That is a great question. We do have interpreter services available onsite, as well as virtually. We do have consent forms available in other languages; we just do the consent form process slightly differently. Most languages are accommodated, but if there is a very specific dialect that is not commonly spoken, then we may just need a little time to ensure that we’ve found an interpreter who speaks that specific dialect.
SE: If somebody qualifies and comes to participate in one of the studies, what kind of benefits do they have participating in one of these food allergy or eczema studies?
FY: I think that's a really important question, and I'm glad you asked. Of course, we love to be able to advance the science, but it's really nice to be able to actually help the patient themselves. And so for patients and their caregivers and families who come to the clinical center at the NIH, it's at no cost to the patient or their family.
They don't need to have insurance, and they will receive the standard of care, excellent quality care, which includes clinical visits and prescription medications at no cost to the patient, and that includes the specialists that we have here at the Clinical Center. And then kind of on a more global or larger scale, what we learn from the patient and their contributions will help other patients like them who aren't able to participate in the trial. It really helps the patient get better control of their eczema and understand their food allergy and access to kind of more knowledge and empowerment, but also helps patients across the globe who have this similar condition and need help as well.
SE: Yeah, I think that's a really great way of putting it. So there's benefits for the people and the families participating. But from a higher level, we want to make sure we're advancing the science and helping out folks who can't participate in the studies. Are there any risks in participating in these studies? We talked about the benefits, but want to make sure we talk about the risks as well.
OA: Of course, blood draw and skin prick testing that are part of our protocols are very low risk procedures that are routinely done in clinical practice. If the participant is found to be eligible for an oral food challenge, basically our team will give the allergenic food or placebo to the participant in gradually incremental doses under very close observation in our pediatric inpatient service. There is a potential risk of an allergic reaction during the oral food challenge, including a severe one called anaphylaxis. Our team will always be at the bedside with the participant during this procedure, and if an allergic reaction were to happen, we will treat it accordingly with the gold standard treatment options specific to participants’ symptoms.
SE: If somebody wants to learn more about the NIH or the NIH’s research in this space, what resources are available to them?
JU: The best place to learn about trials being offered at the NIH is clinicaltrials.gov. If you're interested in learning more about our studies, Ellen is going to tell you about how to get in touch with our team directly.
SE: OK, Ellen, can you tell us a little bit about where people can go to find out more information if they're interested in learning about these studies?
EZ: Absolutely. We would be happy to tell you more information about our study. Please email me at NIAIDFARS2@NIH.gov for more information or to initiate the screening process for eligibility.
SE: That's perfect. Thank you, guys. And a big thanks to the NIH for doing all of this research on food allergies and eczema.
Comments (0)