In this study we want to compare how well two different drugs work to treat kids and young adults that have a narrow or stiff esophagus because of a health problem called eosinophilic esophagitis.
Eosinophilic esophagitis (EoE) is one of the most common causes of swallowing problems in both kids and adults. In this study, there are two groups so that we can compare how well two different drugs work at treating EoE. Group 1 will take the study drug dupilumab, which is given as an injection. Group 2 will take the study drug fluticasone, which is taken by mouth. You or your child will be randomly assigned to one of the groups, like flipping a coin. There are between seven and eight study visits that you or your child will take part in. Two visits will take place over the phone or telehealth. The other six study visits will take place in person at Children's Hospital Colorado. At these study visits we will ask you or your child to fill out surveys about your health. We will also use a needle in your arm or your child's arm to take blood samples at two visits. Two times in the study will do a procedure called an endoscopy, where we put a small tube down your or your child's throat while you/they are under anesthesia. During the endoscopy, we will measure and take pictures of the esophagus. We will also take a small sample (biopsy) of the esophagus. You or your child will also do an esophageal string test. This involves swallowing a small capsule attached to a string so that we can see how well the treatment works. You or your child will be paid for each study visit that is completed.
You or your child may be able to join this study if you or your child are between 10 and 25 years old and have been diagnosed with eosinophilic esophagitis. You or your child may also be able to join if you have two (or more) episodes per week of feeling food stick in your esophagus after swallowing. You or your child can't join this study if you have used dupilumab within 12 months of starting the study. Before joining, a study doctor will review all criteria to make sure you or your child qualify and that it is safe for you to join.
Protocol Number: 23-2367
Principal Investigator