What is the Duke Food Allergy Initiative (DFAI)?

The Duke Food Allergy Initiative (DFAI) was established in 2003 for the study of food allergy in children and adults. Over 12 million Americans, or approximately 4% of the population, suffer from some type of food allergy or anaphylaxis, a medical condition that can be life threatening. According to the Centers for Disease Control, food allergies in the U.S. have increased almost 20% over the past decade. DFAI aims to provide patient care, research, and education for patients with food allergy.

DFAI provides comprehensive family-centered patient care for food allergy and food-related anaphylaxis. DFAI investigators study the biologic basis of food allergy in the laboratory and in clinical research studies. Education of community physicians, allied health professionals, and the public are also a vital part of the mission of the DFAI.

Where is the DFAI located?

The DFAI is located at Duke University Medical Center in the Piedmont region of North Carolina. Duke is approximately 2.5 hours from Charlotte and Wilmington and approximately 3 hours from Richmond, VA. Our patients are seen in the Children’s Health Center at Duke. Clinical studies are conducted in the Children’s Health Center and in the Duke Clinical Research Unit located in Duke South Hospital.

Who is on the medical team?

Wesley Burks, MD, and Brian Vickery, MD, are specialists in the study of food allergy. Each has a special interest in clinical care and research for patients with food allergy. Dr. Burks is the Director of the DFAI.

The faculty is assisted by pediatric or internal medicine physicians who are in training to become allergy specialists.

Other staff members on the team providing care to the patients and families include:

• Pam Steele, CPNP, CRC
• Jan Kamilaris, RN
• Alison Edie, CFNP
• Janie Hainline, RN
• Ginger LaBelle, CPNP
• Debbie Sedlak, CPNP
• Leslie Stanford, RD, LDN

Laboratory Staff:

• Mike Kulis, PhD
• Xiaohong Yue
• Huamei Zhang, MS
• Nikolas Kamilaris

In addition, the investigators at Duke participate in the NIH-funded Consortium for Food Allergy Research (CoFAR), which is a network of food allergy centers that includes, in addition to Duke, Mount Sinai School of Medicine, Johns Hopkins School of Medicine, National Jewish Research & Medical Center, and University of Arkansas for Medical Sciences. CoFAR was established to conduct multi-center clinical trials, observational studies, mechanistic studies and basic research towards further understanding of the best possible treatment approaches for food allergies.

What clinical research is being done?

Clinical research involves the study of new medicines and treatments in order to understand how well they work and if they are safe. Before a clinical research study begins, the physician in charge must present the study plan to a group of physicians, other health care workers, and community members who evaluate the plan for patient safety. Once the study is approved, subjects who meet the study entry criteria are invited to take part. It is always the choice of the patient and his or her family whether or not to enroll in a study. Your decision not to enroll in a study will not affect the care you or your child receive at the DFAI.

Current studies include:

1. High- and low-dose oral immunotherapy for newly-diagnosed young patients with peanut allergy (the DEVIL study) [more]
2. Double-blinded, placebo-controlled study of oral immunotherapy for patients with peanut anaphylaxis [more]
3. Treatment of peanut allergic patients with Xolair and oral immunotherapy [more]
4. Double-blinded, placebo-controlled study of sublingual immunotherapy for peanut allergic patients [more]
5. Desensitization study of peanut allergic patients [more]
6. Immunotherapy for egg allergy [more]
7. The natural history of peanut allergy in high-risk children [more]
8. Desensitization study of egg allergic patients [more]
9. Hypoallergenic formula for infants with milk allergy [more]
10. Reslizumab (anti-IL-5 antibody) for eosinophilic esophagitis [more]
11. Milk oral immunotherapy (with Johns Hopkins) [more]

Future studies include:

1. Oral immunotherapy for peanut allergic adults aged 18-50
2. Oral immunotherapy for tree nut allergy
3. Epicutaneous (on the skin) immunotherapy for peanut allergy

(Note: Please visit this site often for information about additional future studies.)

What basic science research is being done to investigate the problem?

Laboratory studies involving allergies and desensitization are being conducted on both mice and human patients. Blood samples are collected and analyzed for the presence of specific chemicals involved in the allergic response. We are looking for better ways to treat allergies through desensitization and tolerance induction.

Research FAQs

Q: Is oral immunotherapy a cure for food allergies?

A: Although our early research is promising, many questions are still unanswered. We believe that oral immunotherapy may offer some degree of protection from accidental reactions as long as the treatment is continued. However, the process involves a significant daily commitment for years, and some food-allergic patients cannot continue on the treatment due to side effects, In addition, the effect of the treatment might not be permanent. It is, therefore, premature to consider this program curative.

Q: What other possibilities are there for food allergy treatment?

A: The current standard of medical care is strict avoidance of the allergen, education of caregivers at school or childcare settings, and administration of emergency medications in the event of accidental exposure. Although many research groups are developing new treatments, all are investigational at this time and should only be administered in research settings by experienced investigators. We feel that neither our approaches nor any others are currently ready for use in the clinic.

Q: Our family has decided to volunteer for your research studies. How can we find out more information?

A: We thank you for your interest in our research and your willingness to participate. If you would like to discuss if you or your child qualifies for a current or future study, please call Pam Steele at 919-668-1333. We will do our best to return your call as promptly as possible but do ask for your patience as it may take several days for us to respond.

Q: We don’t live in North Carolina but would still like to participate. Can we arrange to travel for the study, or relocate to the area?

A: We appreciate your enthusiasm for our work but we are only able to accommodate those families who live in the surrounding areas because, in our experience, this type of research cannot be done safely over long distances. Due to the high demand for involvement in our studies, we currently maintain a wait list for our studies and give preference to those already living in our community.

Q: My child is allergic to shrimp. Will you be starting other trials soon with different foods?

A: We are always interested in beginning new studies, and at any given time, have several in development. Although we do not have immediate plans to study other food allergens except for certain tree nuts, it may be possible in the future.

Q: We appreciate the food allergy research that Duke and other centers are doing. How can we help support and expand it?

A: You might consider joining a local or national food allergy support group to help raise awareness of the problem. In addition, you can write your congressman or congresswoman to advocate for increased food allergy research funding or consider organizing a fundraiser of your own. If you would like to find out more about making a contribution, please contact us below, and thank you in advance for your support.

How can I contact the Center?

You may contact the Duke Food Allergy Initiative at foodallergy@mc.duke.edu or call 919-684-9914 to schedule a clinical evaluation for your child. Either you or your healthcare provider can contact us to schedule a food allergy evaluation. Please be aware that a clinical visit is different than a research study and that we cannot offer immunotherapy to patients in the clinic.