Testing Effectiveness of Losartan in Patients With EoE With or Without a CTD
Condition: Eosinophilic Esophagitis; Connective Tissue Disorders
MeSH terms: Esophagitis; Eosinophilic Esophagitis; Connective Tissue Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this research study is to test the safety of losartan potassium and see what
      effects (good and bad) it has on you and your eosinophilic esophagitis.
    

Detailed description: 
      Losartan is a drug that 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. Losartan has
      been safe when administered to patients with normal blood pressure. This medication has not
      been studied in people with eosinophilic esophagitis or connective tissue disorder.
      Eosinophils are a type of white blood cell that induces inflammation. Eosinophils with other
      inflammatory cells produce a protein called TGF-β, which may contribute to part of EoE.
      Losartan may reduce the amount of this protein and therefore, be a treatment for eosinophilic
      esophagitis.

      You will be in the research study for approximately 4 months. Participation in this research
      study will involve 9 study visits. Of the 9 study visits, at least 3 visits will take place
      in the clinic; the other visits may take place over the telephone.

      Throughout the study, the following activities will occur:

        1. A physical and vital signs will be obtained

        2. There will be two endoscopies performed one at the beginning and one at the end of the
           study

        3. Blood will be obtained up to three times

        4. Pregnancy tests will be performed

        5. Quality-of-life questionnaires will be completed

      This is an open-label trial, which means that if you choose to enroll and you meet screening
      criteria, you will receive Losartan as a treatment. You will start the study drug at a low
      dose. It will be increased at vist 3 the 1 month visit. The dose of study drug will be
      increased depending on your weight and how well you tolerate each dose but will not exceed
      100mg of study drug per day. It may be increased or decreased during the study if there are
      any side effects. If you do not have certain side effects, you will take each dose of the
      study drug between 21 and 28 days until your next study visit. You will swallow a pill or
      liquid once or twice a day.

      This study will consist of 4 phases: screening, treatment (titration and maintenance), end of
      treatment, and follow-up. Participants that are between 5 to 18 years of age, as well as the
      parent or legal guardian will be asked to complete questionnaires of quality-of-life symptom
      severity questionnaires. Participants between the age of 19 and 21 will also have to fill out
      these questionnaires, but parents/guardians will not have to fill these out. If you are the
      parent or caretaker, the only study activity in which you will be involved is the completion
      of questionnaires about you and your family.
    

Intervention name(s): Losartan Potassium
Intervention type(s): Drug
Intervention description(s): The dose of study drug is dependent on body weight and tolerance but did not exceed 100 mg.
Other intervention name(s): Angiotensin II Receptor Antagonists
Intervention MeSH terms: Losartan; Angiotensin II; Angiotensin Receptor Antagonists
Intervention model: Single Group Assignment
Intervention model description: This study is an open-label study which means that all participants receive the study medicine
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Eosinophilic Esophagitis; Connective Tissue Disorders; Drug trial