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

NCT ID: NCT05587673

Last Updated: 2024-11-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-06
• Study Completion Date: 2024-10-11

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Methylprednisolone

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

Group Type: EXPERIMENTAL

Methylprednisolone

Intervention Type: DRUG

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

Interventions

Methylprednisolone

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Avnesh Thakor

Associate Professor of Radiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Avnesh Thakor, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University

Palo Alto, California, United States

Countries

United States

Other Identifiers

64154

Identifier Type: -

Identifier Source: org_study_id