Budesonide in Patients With Immune Mediated Enteropathies

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-10

Study Completion Date

2021-10-19

Brief Summary

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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.

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Detailed Description

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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) who have had improvement in symptoms and small intestine healing with oral budesonide.

Patients who meet inclusion criteria and agree to enter the study will be included for 12 weeks or until they choose to discontinue or there are concerns for safety.

At the beginning of the study, patients will undergo questionnaires, blood draw, urine and stool collections, physical exam, and an upper scope (esophagogastroduodenoscopy) with biopsies from the small intestine. They will then be randomized to either continued therapy on their current dose and formulation of budesonide (medication provided by the study) or to withdrawal of the medication over 2 weeks and then no medication during the study. Daily questionnaire on symptoms will be recorded.

Patients will be assessed in the clinical research unit monthly during the study with a questionnaire, physical exam, blood draw, and urine/stool collections.

Finally, at the end of the trial (12 weeks) or at the time of withdrawal from the trial, the patients will complete questionnaires, physical exam, blood collection, urine/stool collection, and upper scope (esophagogastroduodenoscopy) with small bowel biopsies.

Conditions

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Enteropathy Celiac Disease CVID Enteropathy Collagenous Sprue Autoimmune Enteropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized, open-label withdrawal of budesonide versus continued budesonide therapy in patients with immune-mediated enteropathies that have had symptomatic and histologic improvement

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Continued Budesonide

Patients in this arm continue budesonide at the dose they were taking at the time of enrollment in the trial

Group Type NO_INTERVENTION

No interventions assigned to this group

Withdrawal of Budesonide

Patients are weaned off of budesonide over 2 weeks and continued off of the medication for the duration of the trial

Group Type EXPERIMENTAL

Withdrawal of Oral Budesonide

Intervention Type DRUG

The intervention arm will taper and stop budesonide therapy (withdrawal).

Interventions

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Withdrawal of Oral Budesonide

The intervention arm will taper and stop budesonide therapy (withdrawal).

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No