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

NCT05587673 | Completed Phase 1 FDA Drug

• 1 other identifier: 64154
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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, 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

Inflammatory Bowel Diseases; Crohn Disease; Ulcerative Colitis; Indeterminate Colitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Number of patients in which pre-procedural and procedural imaging can be correlated with clinical outcomes following therapy

  Month 6

• Number of patients who have molecular changes correlated with improvement in symptoms following intraarterial steroid therapy.

  Month 6

Study Arms (1)

Methylprednisolone

EXPERIMENTAL

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

Drug: Methylprednisolone

Interventions

Methylprednisolone DRUG

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

Methylprednisolone

Eligibility Criteria

• Age: 4 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Palo Alto, California, 94304, United States

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative

Interventions

Methylprednisolone

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Intervention Hierarchy (Ancestors)

Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Avnesh Thakor, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Radiology

Study Record Dates

• First Submitted: October 14, 2022
• First Posted: October 20, 2022
• Study Start: October 6, 2022
• Primary Completion: October 11, 2023
• Study Completion: October 11, 2024
• Last Updated: November 26, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)