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Completed

NCT Number: NCT05587673

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

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.

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Key information

Conditions

Inflammatory Bowel Diseases Colitis Colitis, Ulcerative Colonic Diseases Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Indeterminate Colitis Intestinal Diseases Ulcerative Colitis

Age range

4 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Stanford University

Palo Alto, California, 94304, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

methylprednisolone

Drug

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

Primary outcomes

  1. Number of patients with symptomatic, imaging or biopsy related improvement in their IBD symptoms

    Time frame: 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 outcomes

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

    Time frame: Month 6

    Patients will have their pre-procedural and procedural imaging correlated with clinical outcomes following therapy.

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study 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

Acronym: IBDIR

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Oct 20, 2022
Registry last updated
Nov 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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