NCT05587673CompletedPhase 1
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
Source: ClinicalTrials.gov · Last updated 26 Nov 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 3 (actual)
- First submitted
- 14 Oct 2022
- Start date
- 6 Oct 2022
- Primary completion date
- 11 Oct 2023
- Lead sponsor
- Stanford University
- Diseases
- Crohn's disease, Ulcerative colitis
- NCT number
- NCT05587673
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 3
- From 6 Oct 2022 to the primary completion date, 11 Oct 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with MR unsafe metallic implants that will not be able to undergo the MRI portion of the study.
Other illness
- Patients with contrast allergy.
Lab values
- Patients with renal function impairment (GFR \< 45 mL/min) preventing contrast administration.
Who the study is looking for
- 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.
Age in the registry: 4 years to 25 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Stanford University Coordinator of this site? Confirm its status | Palo Alto | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.