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High Dose Steroid Therapy to Treat Flares in Patients With Inflammatory Bowel Disease (IBD)
Recruiting
I'm InterestedTrial ID: NCT05587673
Purpose
This study will examine whether delivery of high dose steroids, directly into the inflamed
bowel via its arterial blood supply, will be better for treating uncontrolled flares of
inflammatory bowel disease in patients compared to conventional intra-venous or oral
administration of this drug. Patients aged 4-25 years of age will be recruited.
In this study, we hope to also learn how this directed steroid delivery during an active
flare will improve patient symptoms as well as the appearance of inflamed segments of bowel
determined by imaging or biopsy (i.e. at the time of endoscopy). Additional data will
determine how the blood vessels in the bowel affect, and potentially even drive the
mechanisms, of inflammatory bowel disease.
Official Title
A Pilot Study Investigating the Feasibility and Efficacy of Locoregional Intra-arterial Administration of Methylprednisolone as a Bridge Therapy to Treat Symptomatic Flares in Inflammatory Bowel Disease.
Stanford Investigator(s)
Avnesh Thakor
Associate Professor of Radiology (Pediatric Radiology)
Eligibility
Inclusion Criteria:
- Patients with newly diagnosis of inflammatory bowel disease (IBD) or patients who have
an established diagnosis of IBD and are experiencing an acute flare which is not being
controlled with first line therapy
- Patients present with typical IBD symptoms which will include, but are not limited to,
abdominal pain, loss of appetite, rectal bleeding, diarrhea, obstruction, or passage
of mucus.
- Patients referred by the GI team.
- Patients (or guardians/parents) must be able and willing to give consent (or assent
where applicable) and be able to attend all study visits.
Exclusion Criteria:
- Patients with MR unsafe metallic implants that will not be able to undergo the MRI
portion of the study.
- Patients with renal function impairment (GFR < 45 mL/min) preventing contrast
administration.
- Patients with contrast allergy.
Intervention(s):
drug: Methylprednisolone
Recruiting
I'm InterestedContact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Avnesh Thakor, MD
650-736-4747