Eosinophilic Esophagitis

Participants will receive Losartan potassium for 4 months.

Losartan Potassium

Study information on the Consortium for Eosinophilic Gastrointestinal Disorders (CEGIR) website

University of California, San Diego

Northwestern University

Cincinnati Children's Hospital Medical Center

An Open-Label Trial of Losartan Potassium in Participants With Eosinophilic Esophagitis (EoE)

A Preliminary Open-Label Trial of Losartan Potassium in Participants With Eosinophilic Esophagitis (EoE) With or Without a Connective Tissue Disorder

Change from baseline in peak esophageal eosinophil count at the end of treatment visit (or early withdrawal)

Change from baseline in blood and esophageal TGF-beta levels at end of treatment (or early withdrawal)

Children's Hospital Medical Center, Cincinnati

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

National Institute of Allergy and Infectious Diseases (NIAID)

Office of Rare Diseases (ORD)

National Center for Advancing Translational Science (NCATS)

This study is an open-label study, which means that all participants receive the study medicine.

Approximately 10 participants with EoE without a CTD will be enrolled, all of whom will receive the Losartan intervention.

Approximately 5 participants with EoE and CTD will be enrolled, all of whom will receive the Losartan intervention.

Connective Tissue Disorders

The medication dosage for Losartan will change throughout this study slowly increasing to a larger amount. You will start the study drug at a low dose. It will be increased at Visit 3/Week 4, unless you have certain side effects. The dose of study drug will be increased depending on your weight and how well you tolerate each dose and will not exceed 100mg of study drug. It may be increased or decreased during the study if there are any side effects.

Testing Effectiveness of Losartan in Patients With EoE With or Without a CTD

A Preliminary, Open-label Trial of Losartan Potassium in Participants With Eosinophilic Esophagitis (EoE) With or Without a Connective Tissue Disorder.

Tissue samples will be obtained from the esophagus from participants to determine the effects of losartan compared to placebo on the reduction of esophageal eosinophils in participants with eosinophilic esophagitis with or without a connective tissue disorder. It is planned to evaluate the reduction as follows:
% of participants with reduction of eosinophil count to =<1/hpf
% of participants with reduction of eosinophil count to less than 15
Average reduction in eosinophil count
Comparison across groups with and without a connective tissue disorder

Tissue samples will be obtained from the esophagus from participants to determine the effects of losartan compared to placebo on the reduction of esophageal eosinophils in participants with eosinophilic esophagitis with or without a connective tissue disorder. It is planned to evaluate the reduction as follows:
% of participants with reduction of eosinophil count to =<1hpf
% of participants with reduction of eosinophil count to less than 15
Average reduction in eosinophil count
Comparison across groups with and without a connective tissue disorder

Blood and tissue samples will be obtained from participants throughout the study to evaluate losartan on the reduction in levels of transforming growth factor beta (TGF-β pg/mL) in the blood and esophagus.

Blood and tissue samples will be obtained throughout the trial to investigate the number of participants that experience a normalization of the EoE transcriptome, mRNA expression fold difference <2 compared to normal controls in participants with EoE with or without a connective tissue disorder

To evaluate the effect of losartan by utilizing the Patient Reported Outcome questionnaires (metric scoring algorithm) to assess for clinical symptom response.

To evaluate the effect of losartan by a study staff member pathologist scoring the tissue samples by utilizing the histology scoring system. This scoring system was created to express the severity and extent of abnormalities in the gastrointestinal tract that often accompany eosinophilic inflammation.

To determine the safety of losartan by the absences of adverse events will be recorded in participants with Eosinophilic Esophagitis with or without a connective tissue disorder.

eosinophilic esophagitis/kalium

An Open-Label Trial of Losartan Potassium in Participants With Eosinophilic Esophagitis (EoE)

Testing Effectiveness of Losartan in Patients With EoE With or Without a CTD

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