Trials / Completed
CompletedNCT05587673
High Dose Steroid Therapy to Treat Flares in Patients With Inflammatory Bowel Disease (IBD)
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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 3 (actual)
- Sponsor
- Stanford University · Academic / Other
- Sex
- All
- Age
- 4 Years – 25 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Methylprednisolone | High dose steroid injected directly into the inflamed bowel segment(s) via its arterial blood supply. |
Timeline
- Start date
- 2022-10-06
- Primary completion
- 2023-10-11
- Completion
- 2024-10-11
- First posted
- 2022-10-20
- Last updated
- 2024-11-26
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05587673. Inclusion in this directory is not an endorsement.