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

Ulcerative Colitis Clinical Trial

— IBDIR  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05587673
• Other study ID #: 64154
• Status: Recruiting
• Phase: Phase 1
• Start date: October 6, 2022
• Est. completion date: December 2026

Study information

• Verified date: January 2023
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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, 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 25 Years

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.

Related Conditions & MeSH terms

• Colitis
• Crohn Disease
• Indeterminate Colitis
• Inflammatory Bowel Diseases
• Intestinal Diseases
• Ulcerative Colitis

Intervention

Drug:
• Methylprednisolone
High dose steroid injected directly into the inflamed bowel segment(s) via its arterial blood supply.

Locations

Country	Name	City	State
United States	Stanford University	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with symptomatic, imaging or biopsy related improvement in their IBD symptoms	Number of patients who have symptomatic, imaging or biopsy related improvement in their IBD symptoms following locoregional intraarterial methylprednisolone administration into the affected segment of bowel.	Baseline through week 6
Secondary	Number of patients in which pre-procedural and procedural imaging can be correlated with clinical outcomes following therapy	Patients will have their pre-procedural and procedural imaging correlated with clinical outcomes following therapy.	Month 6
Secondary	Number of patients who have molecular changes correlated with improvement in symptoms following intraarterial steroid therapy.	Number of patients who have molecular changes on their pre and post therapy biopsy which can be correlated with improvement in symptoms or imaging data from a patient.	Month 6