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

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Inflammatory Bowel Diseases; Crohn Disease; Ulcerative Colitis; Indeterminate Colitis
• Intervention / Treatment: Drug: Methylprednisolone

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304
      • Recruiting
      • Stanford University
      • Contact: Avnesh Thakor, MD; Phone Number: 650-736-4747; Email: asthakor@stanford.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 25 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: Avnesh Thakor, MD, Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): October 6, 2022
• Primary Completion (Anticipated): December 1, 2025
• Study Completion (Anticipated): December 1, 2026

Study Registration Dates

• First Submitted: October 14, 2022
• First Submitted That Met QC Criteria: October 17, 2022
• First Posted (Actual): October 20, 2022

Study Record Updates

• Last Update Posted (Estimate): January 26, 2023
• Last Update Submitted That Met QC Criteria: January 23, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Inflammatory Bowel Diseases; Crohn Disease; Intestinal Diseases; Colitis; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Neuroprotective Agents; Protective Agents; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
• Other Study ID Numbers: 64154

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No