NCT03866538

Budesonide in Patients With Immune Mediated Enteropathies

Open-label Withdrawal Trial of Budesonide in Patients With Immune Mediated Enteropathies

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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) 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

• Enteropathy
• Celiac Disease
• CVID Enteropathy
• Collagenous Sprue
• Autoimmune Enteropathy

Interventions

Type	Name	Description
DRUG	Withdrawal of Oral Budesonide	The intervention arm will taper and stop budesonide therapy (withdrawal).

Timeline

• Start date: 2019-09-10
• Primary completion: 2021-10-19
• Completion: 2021-10-19
• First posted: 2019-03-07
• Last updated: 2022-08-26
• Results posted: 2022-08-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study