A Study to Evaluate Budesonide in Patients with Immune Mediated Enteropathies

Overview

About this study

The purpose of this study is to to evaluate patients with immune mediate enteropathies for changes in symptoms and histology after budesonide withdrawal compared to continued therapy.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

Inclusion Criteria

  • Patients age 18 years and older.
  • Adult patients with immune mediated enteropathies who have had improvement in symptoms and histology on oral budesonide therapy.

Exclusion Criteria

  • Age < 18 years old.
  • Positive stool gluten testing in patients with refractory celiac disease.
  • Small bowel malignancy or history of small bowel malignancy.
  • Refractory celiac disease type 2.
  • Post-transplant lymphoproliferative disorder associated enteropathy.
  • No prior improvement in symptoms and histology with budesonide therapy.
  • Discontinuation of budesonide therapy prior to the trial.
  • Other concurrent systemic corticosteroids.
  • Other immune mediating medications; for example, but not limited to, azathioprine, 6-mercaptopurine, cyclosporine, methotrexate, anti-TNF monoclonal antibodies, alpha-4 beta-7 integrin inhibiting monoclonal antibody, interleukin 12/23 inhibiting monoclonal antibody, JAK inhibitors.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Adam Bledsoe, M.D.

Open for enrollment

Contact information:

Carol Van Dyke CCRP

(507) 266-7842

VanDyke.Carol@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20455323

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