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Corticosteroid

High Dose Steroids for Inflammatory Bowel Disease (IBDIR Trial)

Phase 1
Recruiting
Led By Avnesh Thakor, MD
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 6
Awards & highlights
No Placebo-Only Group

Summary

This trial will examine if delivering high dose steroids directly to inflamed bowel will help treat uncontrolled flares of inflammatory bowel disease in pediatric patients.

Who is the study for?
This trial is for young patients aged 4-25 with Inflammatory Bowel Disease (IBD) who are having a severe flare-up not controlled by standard treatments. They must be referred by the GI team, able to give consent, and attend all study visits. It's not for those allergic to contrast dye, with certain metal implants, or poor kidney function.
What is being tested?
The study tests if high dose steroids given directly into the bowel's blood supply can better treat IBD flares than conventional methods. It aims to improve symptoms and heal inflamed bowel segments as seen in imaging or biopsy.
What are the potential side effects?
High doses of steroids like Methylprednisolone may cause increased appetite, mood changes, insomnia, elevated blood pressure and sugar levels, weakened bones over time, and higher infection risk.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 6
This trial's timeline: 3 weeks for screening, Varies for treatment, and month 6 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of patients with symptomatic, imaging or biopsy related improvement in their IBD symptoms
Secondary study objectives
Number of patients in which pre-procedural and procedural imaging can be correlated with clinical outcomes following therapy
Number of patients who have molecular changes correlated with improvement in symptoms following intraarterial steroid therapy.

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: MethylprednisoloneExperimental Treatment1 Intervention
Participants who have failed first line therapy and are still experiencing flare symptoms.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Methylprednisolone
2015
Completed Phase 4
~2280

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,474 Previous Clinical Trials
17,501,910 Total Patients Enrolled
Avnesh Thakor, MDPrincipal InvestigatorStanford University

Media Library

Methylprednisolone (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT05587673 — Phase 1
Inflammatory Bowel Disease Research Study Groups: Methylprednisolone
Inflammatory Bowel Disease Clinical Trial 2023: Methylprednisolone Highlights & Side Effects. Trial Name: NCT05587673 — Phase 1
Methylprednisolone (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05587673 — Phase 1
~10 spots leftby Dec 2025
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