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

Primary Purpose

Inflammatory Bowel Diseases, Crohn Disease, Ulcerative Colitis

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Methylprednisolone
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inflammatory Bowel Diseases

Eligibility Criteria

4 Years - 25 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with newly diagnosis of inflammatory bowel disease (IBD) or patients who have a diagnosis of IBD and are experiencing an acute flare )
  • 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.

Sites / Locations

  • Stanford UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Methylprednisolone

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
October 14, 2022
Last Updated
January 23, 2023
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT05587673
Brief Title
High Dose Steroid Therapy to Treat Flares in Patients With Inflammatory Bowel Disease (IBD)
Acronym
IBDIR
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.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 6, 2022 (Actual)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University

4. Oversight

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
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Diseases, Crohn Disease, Ulcerative Colitis, Indeterminate Colitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Methylprednisolone
Arm Type
Experimental
Arm Description
Participants who have failed first line therapy and are still experiencing flare symptoms.
Intervention Type
Drug
Intervention Name(s)
Methylprednisolone
Intervention Description
High dose steroid injected directly into the inflamed bowel segment(s) via its arterial blood supply.
Primary Outcome Measure Information:
Title
Number of patients with symptomatic, imaging or biopsy related improvement in their IBD symptoms
Description
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.
Time Frame
Baseline through week 6
Secondary Outcome Measure Information:
Title
Number of patients in which pre-procedural and procedural imaging can be correlated with clinical outcomes following therapy
Description
Patients will have their pre-procedural and procedural imaging correlated with clinical outcomes following therapy.
Time Frame
Month 6
Title
Number of patients who have molecular changes correlated with improvement in symptoms following intraarterial steroid therapy.
Description
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.
Time Frame
Month 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Avnesh Thakor, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Avnesh Thakor, MD
Phone
650-736-4747
Email
asthakor@stanford.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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