High Dose Steroid to Treat Flares in Inflammatory Bowel Disease

• Status: Recruiting
• Trial end date: 2026-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will examine whether delivery of high dose steroids directly into the bowel via its arterial blood supply will be better for treating and controlling flares of inflammatory bowel disease in patients compared to usual 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 will improve patient symptoms as well as the appearance of inflamed segments of bowel determined by imaging (i.e. an MRI scan) or biopsy (i.e. at the time of endoscopy). Additional data will determine how the blood vessels in the bowel affect, and drive, the mechanisms of inflammatory bowel disease.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stanford University
• Treatments: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

Inclusion Criteria:

• Patients with newly diagnosis of inflammatory bowel disease (IBD) or patients who have a diagnosis of IBD and are experiencing an acute flare )

• 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.