Overview

Budesonide in Patients With Immune Mediated Enteropathies

Status:
Terminated
Trial end date:
2021-10-19
Target enrollment:
0
Participant gender:
All
Summary
Researchers are trying to determine if withdrawal of budesonide therapy in patients with immune-mediated enteropathies doing well on therapy will result in worsening symptoms, histology, quality of life, and micronutrient/nutritional status when compared to continued therapy.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Mayo Clinic
Treatments:
Budesonide
Criteria
Inclusion Criteria

- Patients will be recruited from the Division of Gastroenterology and Hepatology and
the Mayo Clinic in Rochester, MN.

- Adult patients with immune mediated enteropathies who have had improvement in symptoms
and histology on oral budesonide therapy.

Exclusion Criteria

- Age <18 years

- 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.