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.