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

Sponsor

Stanford University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05587673

Collaborator

(none)

Enrollment

Location

Arm

49.8

Anticipated Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Inflammatory Bowel Diseases Crohn Disease Ulcerative Colitis Indeterminate Colitis	Drug: Methylprednisolone	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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.

Actual Study Start Date :

Oct 6, 2022

Anticipated Primary Completion Date :

Dec 1, 2025

Anticipated Study Completion Date :

Dec 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Methylprednisolone Participants who have failed first line therapy and are still experiencing flare symptoms.	Drug: Methylprednisolone High dose steroid injected directly into the inflamed bowel segment(s) via its arterial blood supply.

Arm

Intervention/Treatment

Experimental: Methylprednisolone

Participants who have failed first line therapy and are still experiencing flare symptoms.

Drug: Methylprednisolone

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

Outcome Measures

Primary Outcome Measures

Number of patients with symptomatic, imaging or biopsy related improvement in their IBD symptoms [Baseline through week 6]
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.

Secondary Outcome Measures

Number of patients in which pre-procedural and procedural imaging can be correlated with clinical outcomes following therapy [Month 6]
Patients will have their pre-procedural and procedural imaging correlated with clinical outcomes following therapy.
Number of patients who have molecular changes correlated with improvement in symptoms following intraarterial steroid therapy. [Month 6]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

4 Years to 25 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.