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. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Please contact the study team to discuss whether or not you are eligible to participate in a study.

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 the study team for the most up-to-date information regarding possible participation.

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

  • Refractory celiac disease (RCD) is a rare condition often associated with poor prognosis. Various immunosuppressive medications (IMs) have been used with modest success. We describe outcomes in patients treated with open-capsule budesonide (OB), including those for whom IM treatment failed. Read More on PubMed
  • Refractory coeliac disease is a severe complication of coeliac disease with heterogeneous outcome. Read More on PubMed
  • The literature suggests a lack of consensus on the use of terms related to coeliac disease (CD) and gluten. Read More on PubMed
  • Refractory coeliac disease (RCD) is defined by persistent or recurrent malabsorptive symptoms and villous atrophy despite strict adherence to a gluten-free diet (GFD) for at least 6-12 months in the absence of other causes of non-responsive treated coeliac disease and overt malignancy. Symptoms are often severe and require additional therapeutic intervention besides a GFD. RCD can be classified as type 1 (normal intraepithelial lymphocyte phenotype), or type 2 (defined by the presence of abnormal (clonal) intraepithelial lymphocyte phenotype). Patients with RCD may never have responded to a GFD or may have relapsed despite adherence and initial response to the GFD. RCD type 1 usually improves after treatment with a combination of aggressive nutritional support, adherence to a GFD, and alternative pharmacological therapies. By contrast, clinical response to alternative therapies in RCD type 2 is less certain and the prognosis is poor. Severe complications such as ulcerative jejunitis and enteropathy-associated T cell lymphoma may occur in a subgroup of patients with RCD. The aims of this article are to (1) review recent advances in the diagnosis and management of patients with RCD, and (2) describe current and novel methods for classification of patients with RCD into categories that are useful to predict outcome and direct treatment. Read More on PubMed
  • Nonresponsive celiac disease (NRCD) is a common problem affecting from 7% to 30% of celiac patients. Because NRCD comprises varied and potentially morbid entities, efficient and cost-effective patient care requires knowledge of the specific causes of this disorder. The aim of this study was to determine the common etiologies of NRCD in a tertiary referral center. Read More on PubMed
  • Budesonide controlled ileal release (CIR) capsules deliver budesonide, a glucocorticosteroid with high topical and low systemic activity, to the distal ileum and the proximal colon. In four previous controlled trials in Crohn's disease, remission rates ranged from 51% to 69%. We sought to evaluate the efficacy and safety of this drug in a population of patients in the United States with Crohn's disease. Read More on PubMed
  • The use of corticosteroids in active Crohn's disease often becomes limited by side effects. Budesonide is a potent corticosteroid with low systemic bioavailability due to an extensive first pass liver metabolism. Read More on PubMed
  • Corticosteroids are the most efficacious drugs for inducing remission in active Crohn's disease, but their benefits are frequently offset by serious side effects. Budesonide is a corticosteroid with high topical antiinflammatory activity but low systemic activity because of extensive hepatic metabolism. We investigated the efficacy and safety of an oral controlled-ileal-release preparation of budesonide in patients with active Crohn's disease involving the ileum or ileum and proximal colon. Read More on PubMed

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20455323

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