Status:
TERMINATED
Budesonide in Patients With Immune Mediated Enteropathies
Lead Sponsor:
Mayo Clinic
Conditions:
Enteropathy
Celiac Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 li...
Detailed Description
This study aims to evaluate patients with small intestinal diseases caused by the immune system (refractory celiac disease type 1, CVID enteropathy, autoimmune enteropathy, and collagenous enteropathy...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
September 10 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 19 2021
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT03866538
Start Date
September 10 2019
End Date
October 19 2021
Last Update
August 26 2022
Active Locations (1)
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1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905