Food Allergy Treatment FAQ’s

FOOD ALLERGY TREATMENT:  Frequently Asked Questions

 

Dr.-Randhawa-2-2
Who is Dr. Randhawa? 

Dr. Inderpal Randhawa is a leading specialist with board certifications allergy, immunology, pulmonology, pediatrics, and internal medicine. Dr. Randhawa is the Director of the Gallegos Food Allergy Center at Miller Children’s Hospital, the 6th largest children’s hospital in the United States. The Gallegos family specifically sought out Dr. Randhawa, who treated their own food-allergic son with food immunotherapy, to lead the Food Allergy Center that they created and funded. In addition, Dr. Randhawa is the Founder and Medical Director of the Translational Pulmonary and Immunology Research Center (TPIRC) and its division, the Southern California Food Allergy Institute.

 

Dr. Randhawa gained interest in food allergy while serving as a sub-investigator in an early study utilizing omalizumab (trade name Xolair). Meanwhile, he was witnessing a dramatic and unprecedented increase in the number pediatric patients admitted to the ICU as the result of anaphylaxis. The severity and frequency of these cases drove Dr. Randhawa to question the direction of food allergy treatment. In addition, Dr. Randhawa had experience desensitizing lung transplant patients with life-threatening allergies to critical and indispensable anti-rejection drugs utilizing a patient-specific desensitization protocol. These experiences, and his collaboration with national allergy and immunology specialists, informed Dr. Randhawa’s precision medicine approach to treating food allergy.
For the past 10 years, Dr. Randhawa has been treating patients with life-threatening allergies to peanut, tree nuts, milk, egg, wheat, soy, seafood, seeds, and other foods using precision medicine oral immunotherapy (OIT). As of August, 2016, Dr. Randhawa has successfully treated over 1,400 patients using his unique, research-based OIT protocol, achieving an unmatched 99% rate of success.

What is OIT? 

OIT is food-based immunotherapy for food allergy. OIT is comparable to allergy shots, which have been safely and effectively used in mainstream medical practice since the 1930s. OIT uses a specific, standardized dose escalation of whole food product (i.e. peanut, milk, etc.) over a period of time to induce desensitization (or tolerance) of that food in a food-allergic patient. Studies have shown that patients who regularly eat a maintenance dose after achieving desensitization remain tolerant.
SoCal Food Allergy’s OIT “graduates” are able to eat a normal U.S. dietary intake of their previously allergic food, giving them the freedom to enjoy foods and experiences that previously had been off-limits to them.

What makes SoCal Food Allergy’s Precision Medicine OIT Protocol so uniquely successful?

OIT protocols differ greatly among providers. The protocol developed by Dr. Randhawa, used to treat over 1,400 food allergic children at the Gallegos Food Allergy Center, and now utilized by SoCal Food Allergy is based on “precision medicine.” Precision medicine is an FDA and NIH-supported innovative approach that takes into account individual patient differences, providing clinicians with the ability to select which treatments will work best for which patients.

Unlike other OIT programs that are designed for an “average patient,” SoCal Food Allergy’s precision medicine approach to OIT entails an assessment of each patient’s immune system to predict how that patient will respond to specific food proteins. As a result, our medical team is able to design an OIT protocol that is specifically suited to each patient’s immune system reactivity. The result is unmatched predictability, safety, and long-term success.

What is SoCal Food Allergy’s OIT Protocol?

Every SoCal Food Allergy patient is treated individually. Treatment typically proceeds as follows:

Stage One: Intake and Diagnostics

  • 90-minute consultation with physician including full patient history and examination
  • Lab work and other testing as needed, such as:

                    ⚬     Skin prick testing                                  ⚬     Lung function analysis

                    ⚬     Specific IgE Blood testing (i.e. RAST)     ⚬     GI testing

                    ⚬     Immune function analysis                       ⚬     Patch testing

Stage Two: Diagnostic Review and Recommendations for Treatment

  • Allergy phenotype classification and food categorization (i.e.  “allergic,” “sensitized,” or “tolerant”)
  • Diagnosis of any connected and underlying conditions (i.e. immune deficiency, etc.)
  • Pre-OIT treatment of any underlying and connected conditions (i.e. environmental allergies, asthma, etc.)
  • Physician presents a patient-specific plan for OIT. The patient’s and family’s commitment is necessary to ensure the effectiveness and safety of treatment.

Stage Three: OIT

  • Most patients are safely treated at the SoCal Food Allergy OIT Clinic located across the street from Miller Children’s Hospital where vitals are monitored by a physician, RN, and trained technician. Any patient determined to be at “higher risk” will be treated at the hospital with emergency facilities on site. All patients have 24-hour on-call support.
  • Process:
    • Challenge any foods to which a patient is determined to be “tolerant” at a adult passing dose (i.e. 10-12 grams for most tree nuts).
    • Foods to which a patient is “sensitized” will be subjected to daily dosing with first dose given in office. After approximately 4-6 weeks of home dosing, the patient undergoes an in-office challenge. Once the patient achieves an adult passing dose, he/she is instructed to consume a regular “maintenance” dose.
    • Foods to which a patient is “allergic” will be introduced in the office under monitoring at an eliciting dose (established by results of comprehensive diagnostics and our team’s decade of OIT experience). Patient doses at home for approximately 6 weeks (sometimes longer for peanut), including weekly updoses. Patient returns for an in-office large dose escalation or challenge and continues eating a daily “maintenance” dose until laboratory values allow a reduction in dosing over time.

Stage 4: Long-Term Monitoring and Follow-Up Care

 

What outcomes are achieved by SoCal Food Allergy’s Precision Medicine OIT Program?

We believe that children should be able to eat whatever they want, just like their friends. We’ve delivered on that promise for 1,400 kids, and hundreds more are well on their way.

Larger maintenance doses taken less frequently (i.e. 30 grams peanut eaten monthly) increases patients’ safety, improves their compliance, and allows graduates to consume as much of their former allergen as they want. We aim for our patients to achieve immunological dietary tolerance, where IgE = Zero.

Has the FDA Approved OIT?

The Food and Drug Administration (FDA) is a federal regulatory agency whose primary purpose is to approve and regulate human drugs and biologic agents. The FDA plays a critical role in the advancement of drug treatments where one drug can be widely applied to many patients with a disease. However, the FDA does not approve nor regulate many treatments, and there are several areas that are beyond the purview of the FDA. For example, the FDA does not approve individualized treatments. Additionally, FDA policy expressly states that it “does not approve medical foods” as therapy.
Importantly, lack of FDA approval does not disqualify OIT as a valid and appropriate treatment for food allergy. Many safe and effective medical treatments lack FDA approval, yet, are still widely used. For example, the FDA does not approve allergy shots, a safe and effective treatment utilized by millions of patients for decades.

[1] Disclaimer: The human body reacts differently under the same set of circumstances. Hence, the responses are typical for a majority of the patients. However, each patient’s treatment will depend on the merits of the individual case. These FAQs do not constitute medical advice under any circumstances whatsoever nor are a guarantee of the results of the treatment in any manner.