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Budesonide in Patients With Immune Mediated Enteropathies

NCT03866538 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2022-08-26

Study results available
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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.

Conditions

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

Interventions

DRUG

Withdrawal of Oral Budesonide

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

Sponsors & Collaborators

Principal Investigators

  • Joseph A Murray, MD · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-10
Primary Completion
2021-10-19
Completion
2021-10-19
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03866538 on ClinicalTrials.gov