Clinical Trials Office

Needed: 4 to 26 Year Olds with a Peanut Allergy

What is the purpose of this study?

We want to find out if there is a way to help lower the risk of severe allergic reactions for children and adults with an allergy to peanuts.

Who can participate?

Children, teens and adults, 4 to 26 years old, who have a documented history of peanut allergy may be eligible to participate.

What is involved?

If you choose to participate, you (if you are 18 or older and participating in the study) or your child will be in the research study for 6 to 9 months and be asked to complete 19 to 26 study visits.

You or your child will be "randomized" into one of 2 study groups.  Being randomized means to be put into a study group by chance, like flipping a coin.  There is an equal chance of being in any one of the 2 study groups:  Characterized Peanut Allergen (based on Peanut Flour) or Placebo (an inactive substance).  All study participants will take a daily dose of either peanut or placebo powder, which will be mixed in with another food, such as pudding or applesauce. 

During the study visits at the clinic, you will receive the Characterized Peanut Allergen or Placebo, as well as complete health-assessments, including:

  • Medical history regarding peanut allergy and other allergies
  • Physical exams
  • Vital sign measurements
  • Diet and allergy questionnaires
  • Allergy skin prick test
  • Breathing tests
  • Oral food challenge
  • Desensitization visits
  • Blood and urine tests

You will be given a diary to take home and complete on a daily basis. The diary should be brought with you to each study visit.

Each week you, as the participant or as the parent of the participant, will be contacted on the phone by the research staff.  The research staff will ask how you or your child is feeling and to make sure you or your child is taking the study drug.

When the study is over, the study doctor will determine if you or your child is eligible for participation in in a follow-up study which will continue to monitor the safety of increasing doses of study drug.

A detailed list of procedures will be provided to anyone interested in knowing more about this study. 

What are the benefits?

You or your child may not receive a direct medical benefit from being in this study.  However, the information gained from this study may help researchers understand more about peanut allergy and develop new tests or medications to help you and others in the future.

Will I get all the facts about the study?

You will be given a consent form that thoroughly explains all of the details of the study.  The form covers all of the procedures, the risks, the benefits, the pay, who to contact with questions or concerns and more.  A member of the study staff will review the consent form with you and will be sure that all of your questions are answered. 

Do participants receive pay, compensation or reimbursement?

Participants may receive $50 per completed study visit for their time and travel.

Who should I contact for more information?

Lisa Thornbury Clark

513-803-3663

foodstudies@cchmc.org

Cincinnati Children’s Hospital Medical Center

Division of Allergy and Immunology

3333 Burnet Avenue

Cincinnati, OH  45229-3039

Principal Investigator

Amal Assa’ad, MD

Division of Allergy and Immunology

Cincinnati Children’s Hospital Medical Center