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Volunteer for a Phase 1, Open-Label Study of Sirolimus in Eosinophil-Associated Gastrointestinal Disorders

Current therapy of eosinophilic esophagitis and eosinophilic gastroenteritis is limited to highly restrictive elimination diets or off-label use of corticosteroids. This investigational study will examine the safety and effectiveness of low-dose sirolimus in reducing high blood and tissue eosinophil counts in patients with eosinophil-associated gastrointestinal disorders. Sirolimus is FDA-approved for use in kidney transplant recipients to prevent organ rejection.

Who can participate?

You may be eligible if you:

  • Are 18-65 years old
  • Have eosinophilic esophagitis or eosinophilic gastroenteritis
  • Food allergies or evidence of immunoglobulin E (IgE) sensitization to multiple foods
  • High blood eosinophil count

What does the study involve?

Participants will take sirolimus daily for 2 months and will travel to the NIH 5 times over 5 months for check-ups and blood draws; some participants may require 1-2 additional visits over 1-2 months. Participants will have an upper GI endoscopy at the beginning and end of the study.

Where is the study taking place?

The study is being conducted at the Warren Grant Magnuson Clinical Center at the National Institutes of Health (NIH) in Bethesda, Maryland. The NIH campus is accessible by car and public transportation.

How much does it cost?

There is no charge to participate in this research study. All study-related medical care and procedures are provided free of charge.

Will I receive payment of some kind?

There is no compensation for study participation. Transportation and other expenses may be covered.

How do I find out more or volunteer?

To see if you may qualify or for more information contact:

Patient Recruitment and Public Liaison Office, NIH Clinical Center
Toll Free: 1-800-411-1222 (reference study# 13-I-0094)
TTY: 1-866-411-1010 Se habla español.
Email: prpl@mail.cc.nih.gov
Office hours: 8 a.m.-3:30 p.m. EST

To learn more about this study of sirolimus in treating eosinophil-associated gastrointestinal disorders (trial ID: NCT01814059), visit ClinicalTrials.gov.

Last Updated May 29, 2013

Last Reviewed May 29, 2013