Welcome to our TIP Guide! Please reference this guide for a comprehensive breakdown of the program and what to expect on your food freedom journey.
Table Of Contents
What Is TIP?
The Tolerance Induction Program™ (TIP) is the first remission-inducing treatment for food anaphylaxis. The goal of TIP is to allow patients to achieve food freedom– the ability to eat whatever, whenever, without the fear of reaction.
Who Qualifies for TIP?
The Tolerance Induction Program is offered to all food allergy patients between the age of 18 months – 25 years old*, regardless of the severity or number of a patient’s allergens. TIP can also treat those with pre-existing medical conditions such as EoE, FPIES, and asthma.
*case by case
How Does TIP Work?
Immune System Mapping
All patients begin their food freedom journey with extensive diagnostic testing (skin prick, blood tests, patch test) to map out the immune system and build a patient’s allergic profile. The allergic profile gives us an accurate list of all a patient’s allergens ranging from moderate, to sensitized, to anaphylactic.
Data collected from diagnostic testing allows us to create treatment plans customized to each patient’s unique immune system.
Customized Treatment Plans
Using Artificial intelligence (AI), a patient’s test results are cross-referenced with over 20 trillion data markers collected from every patient that has performed lab testing since 2005 to create a personalized treatment plan. The more patients treated and the more data collected, the more precise treatment plans become.
Food Protein Matching
Once a treatment plan is created, a patient’s immune system is systematically and gradually retrained to tolerate allergens through the escalation of biosimilar proteins. Biosimilar proteins are foods with similar protein structures as those found in a patient’s allergens.
This means your child will never start off dosing their anaphylactic foods. Instead, allergens are only introduced after a patient has been desensitized to them. Using this method, we have been able to achieve reaction rates lower than 1%. You can view current reaction rates here
TIP V. OIT
Through traditional exposure therapy, patients microdose their most anaphylactic allergens in the hope of desensitizing the immune system to “accidental exposure.” Accidental exposure protects patients in the event an allergen is unknowingly consumed, but ultimately still calls for a restricted lifestyle. TIP is not exposure therapy.
Through the Tolerance Induction Program, we work to help patients live freely without restriction. Patients are never exposed to their anaphylactic allergens until after they have built tolerance to them through the escalation of biosimilar proteins. Biosimilar proteins are proteins with a similar structure to a patient’s allergens.
Key Differences
- TIP never begins by introducing allergens
- TIP is safer; TIP Reaction Rates: under 1% ; OIT Rates: 23%**
- TIP has a higher success rate- (99%)
- TIP treats multiple & severe allergies/ pre-existing conditions
- OIT is not practiced consistently across allergists
- OIT negative side effects including a high risk for anaphylaxis
- OIT treats for “Accidental exposure” v. TIP puts food allergies in remission
- OIT generally only treats patients 4 yo and older; TIP treats patients 18 months to 22 years.
** Reaction rates vary practice by practice
Diagnostic Testing
Data is the fuel that drives the Tolerance Induction Program. Patient data is collected through a skin prick test, blood draws, and a patch test gathered at your onboarding and launch visits
TPIRC Diagnostics
TPIRC Diagnostics is a subsidiary of Food Allergy Institute’s parent company, TPIRC. It is the only lab capable of running the testing required to create the detailed treatment plans used in the Tolerance Induction Program (TIP).
Why TPIRC Diagnostics?
All TIP patients are tested for an average of 130 allergens.
TPIRC Diagnostics carries a diverse allergen menu with over 200 allergens and over 60 components (9 of which are exclusive to only 4 labs in the world), while other labs carry less than 10.
Over 30% of these allergens are for component testing to identify the specific proteins in a food a patient is allergic to.
For example, if a patient is allergic to a peanut, they are allergic to one of the 17 proteins in a peanut. Of those 17 proteins, six are the most common culprits of allergic reactions. TPIRC Diagnostics tests for all six peanut proteins, whereas Quest does only 2.
TPIRC Diagnostics yields faster and more accurate results with less blood drawn than other national testing facilities.
Sublingual Immunotherapy (SLIT)
If your child tests positive for environmental allergies, then they will need to be on SLIT (sublingual immunotherapy).
Sublingual Immunotherapy (SLIT) is designed to gradually desensitize the immune system to specific environmental allergens and treats the underlying cause of allergic reactions. Patients in SLIT will gain relief from pollen allergies and see improvement in nasal, eye, and lung symptoms.
Patients for whom SLIT is deemed necessary MUST enroll in SLIT prior to or during TIP, to continue in the Tolerance Induction program.
Why?
Environmental allergies share biosimilar proteins as food allergens. In order to treat certain food allergies, environmental allergies need to be treated as well. Our unique formula was created with extensive research by our founder Dr. Randhawa and specifically designed for TIP patients. SLIT is a saline solution spray that has proteins from environmental allergies. It targets your child’s GI tract and lowers the risk of reaction for environmental allergens
Duration
The typical duration of SLIT is 3-5 years. However, the duration of SLIT therapy is patient-specific and varies case by case.”
How To Get Started
Fill out the get started form & schedule a non-clinical consultation
The first step in your food freedom journey is to fill out our “Get Started” form. After filling out the form, our enrollment department will reach out to you by phone, email, or text to schedule a consultation call.
Free Consultation
During this call, your enrollment specialist will thoroughly review TIP and answer your non-clinical questions about the program. Many families use this call to decide if TIP is the right fit for their family.
Next Steps
Financial acknowledgment TIP Fee & Food Intake Form
Once the consultation call has been completed, families will receive a Financial Acknowledgement and Food Intake Forms via email to complete and submit.
The Financial Acknowledgement Form is a signed acknowledgement of the costs of the Tolerance Induction Program™.
Families will then receive an invoice for their TIP program deposit. This fee is used for the development of the patient’s personal treatment plan. The fee is fully refundable prior to your first appointment should you decide not to move forward in the program. To learn more about program costs, please refer to our TIP Fee Guide.
Schedule Your first appointments
Once the Financial Acknowledgement Form, deposit, and Food Intake Questionnaire have been submitted, the patient will receive a notification to schedule their TeleBoarding and Onboarding appointments.
Appointment Types
*Appointment scheduling and duration may differ depending on a patient’s location and patient plan.
TeleBoarding (Virtual 45 mins)
This visit will be completed via a video call with one of our physicians to review your child’s current food consumption, medical history, and to answer your basic questions about the program.
Onboarding (1 day 2 – 3 hours)
At your first in-person appointment at our clinic, we will conduct extensive diagnostics to obtain a complete picture of the patient’s immune system and allergic profile. This includes skin prick testing and blood testing that allows our medical team to evaluate over 300 biomarkers for your child. These results will be presented at your next Launch visit with your custom program plan
Launch Appointment
Day 1 – Patch Day (40 mins)
A patch that contains physical food allergens will be placed on the patient’s back.
This enclosed patch will remain on their back for 24 hours. The patch protects the patient’s skin from air/oxygen, which prevents the patient from experiencing any discomfort or reaction from the allergens.
The skin patch test allows us to assess how your child’s GI tract reacts to various allergens. Please keep the patch clean and dry, avoiding any heavy activity and sweating during the test. A pulmonary function test and ENO will also be performed this day for patients over the age of seven.
Day 2 – Launch day (3.5 hours)
During Launch day, the patch is removed, and results are recorded while you meet with one of our physicians to review the results and your child’s treatment plan based on our analytics.
Our staff will thoroughly go over your at-home dosing regimen with you, and patients will complete their first Food Challenge.
Days 3+ – Food Challenges ( 60 mins)
The third, fourth, and fifth day of the Launch visit will be Food Challenges. This is when your child will officially start treatment. Since each child’s plan is individualized, some patients may need additional visits for their treatment plan.
Zone 1 (Pacific + Mountain Time Zone + Arizona) 8-10 Weeks from onboarding for 2 days of appointments.
Zone 2/3 (Central + East Time Zone + Alaska + Hawaii + International) 16 weeks from onboarding for 5 days of appointments.
After you leave Launch your main job at home is to prepare your child for their Food Challenges by conditioning their immune system to tolerate each protein. This is done by feeding your child small amounts of the treatment food.
Treatment Food Categories
While you are away from the clinic, your treatment will be broken up into three parts.
1) Recommended foods should be consumed 3-5 times a week any time during the day. These are foods that precondition the immune system for the most anaphylactic foods. Examples are: stone fruits, apples, and pears (Depending on your child’s plan there may be other foods).
2) Maintenance foods will be consumed daily in the morning. These are going to be the foods your child has already conquered in the clinic.
3) Treatment foods are the biosimilar foods your child needs to eat once every day to build tolerance for your next Food Challenge. After consuming treatment foods, your child needs to refrain from any activity that will increase their heart rate for one hour.
For nuts, seeds and legumes the Food Allergy Institute will provide the milligram dosing for you in the form of a gummy, and when the treatment foods go to teaspoon dosing you will need to provide the products.
Food Challenge Appointments (45 Mins)
During a challenge visit, patients will typically challenge a food that contains proteins similar to those in their allergens. This may include foods to which they have tested negative to or have never been exposed to.
The patient will then exercise in our facility for 5 minutes, to get their heart rate above 150-160 beats per minute. If no reaction occurs after close monitoring, a patient has successfully passed their challenge!
Food Challenge visits are repeated until all allergens are successfully passed. Compliance to at home dosing and attending all Food Challenge visits is mandatory to successfully complete the program in the timelines presented in your plan.
Food Challenges occur on average:
Zone 1 (Pacific + Mountain Time Zone + Arizona) every 8-10 weeks for 1 – 2 days of appointments. (6 Trips)
Zone 2 (Central + East Time Zone + Alaska + Hawaii) every 10 – 12 weeks for 2-3 days of appointments. (5 Trips)
Zone 3 (International) every 12 – 14 weeks for 3-5 days of appointments. (4 Trips)
Tolerance Appointments (2 Visits 4 months apart)
Prior to your child achieving remission, they will be in the Tolerance phase. Tolerance is the ability to consume large and infrequent amounts of food proteins on a regular basis with no reaction.
During this phase, your child will undergo a systematic transition away from daily protein exposure and will reduce their frequency of maintenance foods. This crucial transition phase tests your child’s ability to eat allergens in varied amounts at less frequent times.
Remember that routine exposure is key in keeping the tolerance you have built up during the program. At this phase in treatment, your provider will encourage you to take one day every week to try something new! During this time, patients can stop reading food labels, eat cross contaminated foods, and enjoy the final step towards food freedom.
The timing between Tolerance visits differs from typical Food Challenge visits. This phase includes two visits, where there is a crucial four month period of transition to ensure Remission success.
Remission Visit – Food Freedom (Annual)
When your child reaches the end of treatment they will be in Remission. This means they will be able to eat whatever they want, whenever they want, without risk of reaction.
In clinical terms, this means a patient’s immune system has successfully built tolerance and achieved “sustained unresponsiveness” – or no longer reacts to allergens as a threat. Remission requires one annual office visit per year that will consist of:
- Doctor’s consultation
- Skin prick test
- PFT/ENO for patients 7yo or older
- Foundation Lab blood draw.
After each visit, FAI will update your child’s Remission Plan and modify how frequently your child needs to consume their major allergens.
Maintaining Remission
The program is designed to move your child into deeper and deeper states of tolerance, through large and infrequent exposure to their once anaphylactic foods.
Remission patients will have a minimum dose of the lead food in each of their allergen groups that will drop down in frequency over time. This minimum dose will be required indefinitely to ensure your child’s ongoing tolerance and ability to freely eat.
“Umbrella Food”
Completely unique to FAI, the molecular testing done at our organization allows us to understand the relationship between a patients’ immune system and the proteins in the different classes of nuts.
What does this do for you?
For example, if a patient is allergic to walnuts, pecans, and hazelnuts, they only have to eat one of them to maintain safety for all three. We call this food an “umbrella food” – a food which houses the most complete set of food proteins to which your child is allergic. Eating the proper amount of the umbrella food will protect your child from a larger group of related allergens.
Glossary
Anaphylaxis plan – action plan for what to do in the event of a reaction or accidental ingestion
Anaphylaxis Kit or Scenario Kit – Set of emergency medications patient should carry at all times for safety
Athena – the electronic medical record (EMR) used in clinic
Biobank – A part of our research department, the storing of biological samples used for research
Call Center – customer service center for scheduling, billing, clinical questions
Campus – collection of buildings belonging to the institute
HQ or Headquarters – Glass building 701 E 28th Street Long Beach, CA
Willow – Challenge clinic located at 2704 East Willow Street in Signal Hill, CA
2790 or TPIRC Clinic or the Blue Building – Pulmonary, Gastroenterology, Immunology Specialty Clinic for TPIRC located at 2790 Atlantic Blvd, Long Beach, CA
Food Lab – warehouse where gummies and doses measured and packaged located at 10572 Calle Lee, Los Alamitos, CA. Also where SLIT is located
San Diego Clinic- Our most recent challenge clinic expansion located at 2067 W. Vista Way , Suite 250 Vista CA, 92083
Capped Foods – foods that need to be eaten at a specific amount but not more than specified
CC – cross contamination
Challenge – monitored clinic visit where patient eats large amount of protein and exercises
Challenge Clinic – Clinics located on Willow & In San Diego where all of the challenge appointments take place
Cybernetics – the TPIRC approach to medicine, the science of communications and automatic control systems in both machines and living things
Denatured – Boiled or cooked protein to change the molecular structure
DW – Dosing worksheet
DEY- Duck Egg Yolk
DEW- Duck Egg White
E-Kit or Code Box – clinic emergency medication box
EMR – Electronic medical record, patients clinical chart
ENO – Exhaled nitric oxide test is a lung test to evaluate indirectly for inflammation
FAI – Our company name Food Allergy Institute
FDS – Food Dosing Strategy is the treatment road map of plan laid out by visit
Food Freedom – The ability for our patients to eat whatever they want, whenever they want, in unlimited quantities without fear of reaction
Food Lab – warehouse where gummies and doses measured and packaged located at 10572 Calle Lee, Los Alamitos, CA. Also where SLIT is located
Food Pantry – in clinic resource for patients to buy hard to find food items
Foundation Labs – is our in house high complexity laboratory located on 3rd Floor of HQ
Gummy or Gelatinization – milligram protein dosing encased in gelatin for TIP treatment
HEW – Hen egg white
HEY – Hen egg yolk
HID – Contact tracing device, safety measure for COVID
HIPAA – Health Insurance Portability Accountability Act enacted to protect patient confidentiality
Intake Q – online form intake platform
Introduction – a monitored in clinic visit where a small amount of allergen is introduced
Kitchen Table – ‘The Kitchen Table’ is the patient facing Facebook group page
Launch Visit – Visit where family received their treatment plan and starts their first food challenges (historically referred to as Food Allergy 2 or FA2)
Launch Pad – the glass building clinic space that houses all the first visits: On-Boarding and Launch at 701 E. 28th Street Long Beach, also referred to as HQ
Maintenance Foods – Foods that patients have successfully challenged and now consume daily or weekly
On-Boarding Visit – the first on site visit where skin prick testing and blood testing done (historically referred to as Food Allergy 1 or FA1)
Pantry – also referred to as ‘The Pantry’, the Facebook page focused on patients in the enrollment process.
Patch Day – the day prior to Launch Visit where Patch test is placed, approximately 15 minute procedure appointment
Patch test – a test where food is applied to the back under an adhesive cover to evaluate gastrointestinal response to foods
PFT – Pulmonary function test is a lung test to check function
POC – provider on call is the provider taking all urgent reactions and emails that day
Pod – medical teams A,B,C consisting of MAs, LVNs, Providers, Physicians
Procedure Room – PFT, SPT and patches performed
QEY- Quail Egg Yolk
QEW- Quail Egg White
QSTAR – Quality Safety Tracking and Reconciliation process
Recommended Foods – safe pre-treatment foods
Referral Coordinator- Responsible for coordinating specialty care for patients in need of external/internal consultation as required
Remission – completion of the program and absence of clinical disease
Remission Visit 1 – the first Remission visit
Rx – Prescription for medication
RXN – Reaction
SLIT – Sublingual immunotherapy, which is the treatment of environmental allergies
Snapshot – visual graphic of a patient’s allergic profile
SPT – skin prick test to evaluate histamine response to food or environmental allergens
Tele-Boarding Visit – the first telehealth visit where the physician takes the medical history
TIP – Tolerance Induction Program, our trademarked treatment program that induces tolerance to food allergens through the use of biosimilar proteins
TIP Connect – patient facing informational website
Tolerance Visit – Transitional visits to get patients from daily dosing to weekly dosing where patients are eating large amounts of food allergens 6 out of 7 days a week. (Typically between Tolerance Visit 1 and Tolerance Visit 2 there is a four month time gap.)
TPIRC – Translational Pulmonary and Immunology Research Center
Treatment Foods – foods built up at home over the course of weeks
Zone 1 – refers to patients coming from pacific and mountain standard time zones
Zone 2 – refers to patients coming from central and eastern standard time zones
Zone 3 – refers to patients coming from out of country