We are currently recruiting participants for the COMFORT Toddlers Study, evaluating an investigational treatment that may help retrain the immune system and potentially reduce the risk of allergic reaction to peanuts.
Your child may qualify for the COMFORT Toddlers Study if they:
- Are 1-3 years of age
- Have been diagnosed with or are suspected of having a peanut allergy based on an evaluation from their doctor
- Are on a strict peanut-free diet
- Have access to emergency medicines (including epinephrine) and a current food allergy emergency action plan
Compensation may be available. No health insurance is required.
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What happens if I fill out the pre-screening questionnaire?
If your child passes the initial study screener, we will match them to a COMFORT Toddlers Study location in your area that is enrolling children with peanut allergy into the study or notify you when one becomes available. If there is not a current study site located in your area, a Patient Engagement Specialist may reach out to you in the future via the email address or phone number (call or text) you provided to share information about new study opportunities your child may qualify for.
Keep in mind that study participation is entirely voluntary.
About Peanut Allergies
Peanut Allergies are one of the most common food allergies in the world.1 They can cause life-threatening reactions and are a serious concern, especially for parents of young children.
Symptoms can be experienced in many ways, ranging from mild to severe:
- Skin reactions (hives, redness, and swelling)
- Digestive issues
- Respiratory difficulties
- Throat swelling
- Anaphylaxis
- Loss of consciousness2
Some children may outgrow their peanut allergy, but it is typically a lifelong condition. Management involves strict avoidance and carrying epinephrine (epi-pens), for allergic reactions. A new treatment option, a patch-based skin therapy, is currently being investigated.3
Frequently Asked Questions
What is a clinical research study?
A clinical research study (also called a clinical trial) is a medical study that helps to answer important questions about an investigational drug—these may include how well an investigational study drug works for a certain condition. All medications must be tested in clinical research study before they can be approved and prescribed to patients.
Why are clinical research studies important?
A clinical research study is the process by which new and innovative medications, interventions and treatments are approved and brought to market, so people can live happier and healthier lives.
Even over-the-counter medications, such as NSAIDs, you may have used to counteract a headache, have gone through the clinical research study process before it was available at your local pharmacy.
Will I be reimbursed?
Those who qualify to take part in the study may be compensated for completion of key study visits. Please discuss this with the study team when they contact you.
What else do I need to consider?
The research team will be able to explain more about what the COMFORT Toddlers Study will involve, and it is up to you to decide if you want your child to take part. Participation in this study is voluntary. Whether or not you decide to participate in this study will not affect your current or future relationships with your doctors.
How far is the study site?
We will match your child to a study site within a close travel distance from your home. If we are not running the study in your area currently, with your permission, we will keep your child in our database and reach out once a study in your area becomes available. If, at any time, you decide you no longer want your information stored, you can opt out and we will delete your details.
About the COMFORT Toddlers Study
The COMFORT Toddlers Study is collecting additional safety data for an investigational treatment option in toddlers aged 1-3 years old. The treatment has already been tested in toddlers and children and has shown that it may help with peanut allergies.
Toddlers who are in the study will be randomly assigned, like the flip of a coin, to receive the active study patch or a placebo patch (which looks like the study patch) but contains no active ingredients. Each child has a 75% chance of receiving the active study patch. Neither the study doctor nor the study participant will know if they are using the active or placebo patch until after the study is over.
The COMFORT Toddlers Study is looking to enroll around 480 children globally, ages 1-3, with peanut allergies. The initial part of the study will last approximately 7 months. This will include a 6-week screening period (to confirm if your child is eligible), a 26-week treatment period, and a 2-week follow-up period. During the study, you and your child will visit the study site 8 times.
To confirm your child is eligible to participate, a 2-day food challenge will be completed during the screening period consisting of exposure to food containing peanuts or food without peanuts. This is to help researchers evaluate your toddler's peanut allergy. More details will be given to you and opportunities to ask any questions will be available prior to choosing to participate.
Following the first 7 months, your child may enter an extension period for an additional 18 months. During this period, all study participants will receive the active treatment.
If you choose to participate and if your child qualifies, they may have access to a new investigational treatment that may help improve their peanut allergy symptoms.
Study participants will receive study-related care and treatment at no cost. You may also receive compensation for completion of key study visits. No insurance is needed.
Who can participate?
Your child may be able to take part in the COMFORT Toddlers Study if they:
- Are 1-3 years of age
- Have been diagnosed with or are suspected of having a peanut allergy based on an evaluation from their doctor
- Are on a strict peanut-free diet
- Have access to emergency medicines (including epinephrine) and a current food allergy emergency action plan
The study team will go over all requirements and the details of the study with you to see if your child may qualify.