drugset / Trial / NCT05587673

High Dose Steroid Therapy to Treat Flares in Patients With Inflammatory Bowel Disease (IBD)

NCT05587673

Phase 1 Completed 3 enrolled Stanford University
NaSingle-groupOpen-labelTreatment

Summary

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, the Investigator hopes 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.

Timeline

Start
2022-10-06
Primary completion
2023-10-11
Completion
2024-10-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Methylprednisolone Other / unclassified Other