Budesonide in Patients With Immune Mediated Enteropathies (NCT03866538) | Clinical Trial Compass
TerminatedPhase 4
Budesonide in Patients With Immune Mediated Enteropathies
Stopped: Study recruitment was difficult and not acheived
United States1 participantsStarted 2019-09-10
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.