Children, Teens and Adults 5 to 25 Years Old who have been Diagnosed with Eosinophilic Esophagitis (EoE) Needed for a Research Study

Why are we doing this research?

Cincinnati Children’s is conducting a research study, sometimes known as a clinical trial or clinical study, to test the safety of Losartan potassium. The doctors also want to see what effects (good and bad) it has on you and your Eosinophilic Esophagitis (EoE).

Losartan is approved by the United States Food and Drug Administration (FDA) for use in adults and children over 6 years of age who have high blood pressure. However, it is considered investigational for this study because it has not been approved to treat EoE.

Who can participate?

Children, teens and adults, 5 to 25 years old, who have been diagnosed with EoE may be eligible for participation.

Children, teens and adults who have been diagnosed with a connective tissue disorder (CTD) may also be eligible to participate.

Conditions

  • Eosinophilic Disorders - EoE

What will happen in the study?

If you (as a participant 18 or older) or your child qualify and you decide to take part in the study, you will have 7 to 9 study visits over the course of about 5 months. Six study visits will take place at Cincinnati Children’s and the rest of the visits will be over the phone.

Throughout the study, you/your child should stay on the same diet and not take medication that is not allowed, if possible.

These are the things that will happen to you/your child while in the study:

  • Demographic and Medical Questions: study staff will ask questions about you/your child and your health, diet, quality of life, symptoms and family history
  • Exam: the doctor will examine you/your child’s ears, nose, throat, chest and skin
  • Vital signs: study staff will take you/your child’s height, weight, blood pressure, heart rate, breathing rate, and temperature measurements
  • Blood Sample: you/your child may be asked to provide a blood sample
  • Endoscopy Biopsies: during 2 endoscopies (part of you/your child’s standard of care), the doctor will collect up to 4 extra esophageal biopsies (a small piece of tissue from the esophagus) for this study
  • Urine Pregnancy Test: if you/your child are a female who has started her period, you will provide a small urine sample for a pregnancy test
  • Losartan: you/your child will take the study drug Losartan
  • Diary: you/your child will fill out a diary at home

Interested parents, guardians, and/or participants will be given a consent form that thoroughly explains all the details of the study. A member of the study staff will review the consent form with you and will be sure that all your questions are answered.

What are the good things that can happen from this research?

If you agree to take part in this research study, there may not be a direct medical benefit for you/your child; however, the information learned from this research study may benefit other patients with EoE in the future.

What are the bad things that can happen from this research?

A detailed list of possible side effects will be provided to those parents and/or participants interested in knowing more about this study.

Will you/your child be paid to be in this research study?

Participants will not receive compensation for their time, effort and travel for this study.

Contact

Contact Us.Leanne Ray
leanne.ray@cchmc.org
513-803-5446
Cincinnati Children’s Hospital Medical Center
Division of Allergy and Immunology
3333 Burnet Avenue
Cincinnati, OH 45229-3039

Study Doctor

Contact Us.J. Pablo Abonia, MD
Cincinnati Children’s Hospital Medical Center
Division of Allergy and Immunology