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Remind Me Of Why This Is Awesome?
Fewer than 10% of Americans participate in clinical research which seems crazy. You, on the other hand, have figured out the following benefits:
At 1nHealth, we hope you’re as excited as we are to build the future of health together.
Frequently Asked Questions
A food allergy is an immune response to certain foods that can result in reactions such as hives, tingling or itching in the mouth, digestive problems, and swelling in the throat, face, or other areas. These immune responses can have differing levels of severity and can even be life-threatening.
The purpose of this study is to determine whether Intrommune’s specialized toothpaste, called OMIT toothpaste, can be used safely in adults. This study will also assess the dose for daily use, incidences of adverse reactions or lack thereof, and any changes in allergen reactivity while using the toothpaste.
OMIT stands for oral mucosal immunotherapy and here is how it works: OMIT toothpaste (INT301) contains allergen proteins that coat the inside of the mouth and then interact with special immune cells in the mouth. Brushing with the toothpaste daily over time may result in the user desensitizing to the allergen – resulting in a diminished allergen response when exposed to peanuts.
Yes, there are some risks involved in this study, but steps are taken to minimize the likelihood and provide support if any adverse reactions occur. For example: the patient will have to participate in an oral allergy test, and so the study site is prepared with trained healthcare professionals to monitor and treat any adverse reactions including anaphylaxis.
No. You do need a doctor’s diagnosis and a recorded history of a peanut allergy.
Yes! There is compensation available for your time and participation. Participants will receive $150 for the visit requiring an oral allergy test, and $75 each for any other type of visit.
After completing the pre-screener questionnaire on this page, prospective participants will receive notification of whether or not they can continue on to the next portion of eligibility screening which will happen at the study site. The eligibility screening will include an oral allergy test to be done under careful monitoring by site staff.
Participants will go through a screening period (<28 days) where allergy and personal health data are collected. Participants will then be randomly assigned to either the control group or the treatment group. Participants will need to complete study tasks throughout the 8-week treatment period, and compensation will be given for time and participation at certain milestones during participation.*
Participation in this study includes a screening period where patients will receive a physical exam, an oral food challenge, training, and other study-related exams and activities. Each patient will receive their own epinephrine injector. After the screening period is over, participants will need to brush regularly with the provided toothpaste (the OMIT toothpaste, or a placebo toothpaste) and complete a daily diary for 8 weeks.*
From baseline to finish, the total study time is approximately 14 weeks, with just 8 of those weeks requiring using the OMIT toothpaste. There are 8 in-person visits to the study site, and a few phone calls. Once enrolled, the treatment does not change the participant’s daily routine beyond the change in toothpaste, and a quick daily diary. *
Unicorn Hunters is a reality television series that debuted in 2021, where expert panelists decide whether or not to fund potential “unicorns” (companies that could become valued at over $1 billion dollars.) When Intrommune appeared on the show, the panelists seemed impressed by the possibility of this unique food allergy treatment and agreed that there was unicorn potential, offering to help fund further development and research.
All costs related to the study are paid for by the sponsor.
The study doctor and some members of the study team will be able to see your health information and it will be used for the purpose of this study ONLY.
Yes. Your decision to be a part of this study is entirely voluntary. You can decide to stop study treatment at any time during the study. If you wish to end your participation, please let the clinical study team know.
*Please note: The specific study timeframes listed here are subject to change in the future.