About the Study
A peanut allergy can be severe and life-threatening if not treated promptly. Peanut allergies are one of the most common food allergies in children in the USA, with more than 2% of children being affected. While there is no cure for a peanut allergy, researchers are exploring ways to make the impact of this allergic reaction less severe.
Researchers are exploring the potential effects of a new study medication because they understand that a peanut allergy is not only dangerous, but it can impact a child’s emotional and mental health as well. That’s why they want to help – but they need you and your child. If your child has been diagnosed with a peanut allergy, why not consider signing them up to be part of this groundbreaking new study? Join now and help researchers help children like yours today!
- Participants may be compensated up to $100 per study visit.
- Participants will receive a new potential treatment for their peanut allergy at no cost.
- Participants will be contributing valuable information that may benefit those with peanut allergies in the future.
- Participants will be helping to advance medical research.
- If you or your child decide to participate in the study and later feel that you no longer wish to be part of it, you can withdraw at any time.
- Any information that you or your child provide will be kept strictly confidential, except as required by law.
- Qualified health professionals will monitor your child’s health as it relates to the study.
Who Can Participate?
- Children aged 4-11 who are diagnosed with a peanut allergy
- Child must not have severe or unstable asthma
- Child must not have any medical condition in which epinephrine (adrenaline) as a treatment is inadvisable
- Child must be able to receive treatment for an asthmatic response such as inhaled beta-2-agonist or anticholinergic medication
- Child must not have severe skin disorders (e.g., severe generalized poorly controllable atopic dermatitis)
- Child must not have ever tried a treatment to make them less allergic to peanuts, either in a formal study or in clinical practice
- Child must not have participated in another interventional clinical trial in the last 30 days
- Child must not have undergone major surgery within the past 3 months or have an anticipated major surgery during the study period
- Child must not have ever fainted or felt lightheaded and sweaty after getting a blood test or a shot
- Child must not have any significant medical conditions (besides asthma and atopic dermatitis)
More Study Details
The study team will explain the research study in its entirety but some details are:
- You will take part in a preliminary phone screen to check your child’s allergy history and other general eligibility checks before being invited for a screening visit.
- Visit one will include giving informed consent and participating in screening assessments. If the participant remains potentially eligible they are invited to participate in a d food challenge over 2 separate visits.
- The food challenge involves your child eating specific increasing amounts of peanut or placebo (no actual peanut content) in a slow, graduated fashion over several hours, under medical supervision. On each day of the food challenge, your child will be fed small servings of a chocolate pudding mixture containing either peanut or placebo. The food challenge will be performed in a double-blind manner, which means that neither you, your child, or the study doctor will know whether your child is eating the peanut or placebo mixture on each day. If your child has reacted sufficiently to the peanut food challenge they are considered eligible and return for the randomization visit 4 weeks later.
This research study is taking place in several locations. To see if there is a research site near you, please see below.
Research Site: Children’s Healthcare of Atlanta
Location: 1400 Tullie Road NE | Atlanta, Georgia 30329
Lead Researcher: Dr. Brian P. Vickery
Research Site: Massachusetts General Hospital
Location: 55 Fruit St. Boston, Massachusetts 02114
Lead Researcher: Dr. Wayne Shreffler, MD, PhD.
Research Site: Arkansas Children’s Research Institute
Location:11 Children’s Way • Slot 512-13 • Little Rock, AR 72202
Lead Researcher: Kim Norris
Research Site: John Hopkins Baltimore
Location: 550 N. Broadway, Suite 511 Baltimore, MD 21205
Lead Researcher: Dr. Robert A. Wood
Research Site: Peninsula Headlands
Location: 550 Deep Valley Drive, Suite #317, Rolling Hills Estates, CA 90274
Lead Researcher: Dr. Lawrence D. Sher, M.D
This study has been reviewed and approved by the Advarra Institutional Review Board.