Kids and Teens with EE (Eosinophilic Esophagitis) Needed for Research Study
What is the purpose of this study?
Cincinnati Children’s is conducting a research study to evaluate the effects of an experimental drug, reslizumab, in treating eosinophilic esophagitis in children, adolescents and teens.
Who will be included in this study?
Children, adolescents and teenagers between the ages of 5 and 18 years old with eosinophilic esophagitis may be eligible to participate.
What is involved?
The study lasts for 18 weeks and includes 6 visits. The following is a list of procedures that will take place during the study:
- Screening visit with physical exam and upper endoscopy
- 4 infusion visits, one month apart
- 9 weekly phone calls
- 1 follow-up visit with upper endoscopy
What are the benefits?
Your child may receive no direct benefit from participating in this study. The greatest benefit is that your child may be contributing to research that helps other children. Clinical studies are essential in finding new and improved treatments and diagnostic tools.
Will I get all the facts about the study?
Parents interested in having their child participate 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. Study procedures will not begin until a parent or guardian has signed this form and, if of age, the child has given at minimum his/her verbal agreement.
What are the risks?
The risks of participation include the potential for headaches, cold symptoms and muscle tenderness or pain.
What is the pay?
Participants will be paid for study time and effort.
Who should I contact for more information?
Cindy Schulze
Cincinnati Children's Hospital Medical Center
Department of Allergy and Immunology
MLC 2000
3333 Burnet Ave., Cincinnati, OH 45229-3039
Phone: 513-636-0740
cynthia.schulze@cchmc.org
