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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
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
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 6
Awards & highlights

IBDIR Trial 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.Check my eligibility
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.See study design
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.

IBDIR Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been newly diagnosed with IBD or my IBD is flaring up and not controlled by first-line therapy.

IBDIR Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of patients with symptomatic, imaging or biopsy related improvement in their IBD symptoms
Secondary outcome measures
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.

IBDIR 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
2,378 Previous Clinical Trials
17,333,329 Total Patients Enrolled
9 Trials studying Ulcerative Colitis
232 Patients Enrolled for Ulcerative Colitis
Avnesh Thakor, MDPrincipal InvestigatorStanford University

Media Library

Methylprednisolone (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT05587673 — Phase 1
Ulcerative Colitis Research Study Groups: Methylprednisolone
Ulcerative Colitis 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the scope of participants in this research endeavor?

"Affirmative. According to the data posted on clinicaltrials.gov, this medical experience is presently inviting patients to participate. It was first announced on October 6th 2022 and has seen one update since then, on October 17th 2022. The research team seeks 30 individuals from a single location for their trial."

Answered by AI

Who is eligible to participate in this research program?

"This medical trial is searching for 30 participants aged between 4 and 25 that suffer from inflammatory bowel disease (IBD). To be eligible, these individuals must present with common IBD symptoms such as abdominal pain, loss of appetite, rectal bleeding, diarrhea or obstruction. Additionally, they need to have been referred by the GI team and agree to provide consent/assent in order to attend all subsequent study visits."

Answered by AI

Does this clinical trial accept participants below the age of thirty?

"The parameters for inclusion in this medical trial are 4 years old to 25 years old."

Answered by AI

Does this research endeavor have open enrollment?

"As per the information available on clinicaltrials.gov, this research initiative is still actively looking for participants to join. It was posted online initially on October 6th 2022 and has seen its last update take place on October 17th of that same year."

Answered by AI

Are there any serious risks associated with Methylprednisolone consumption?

"As this is a first-phase trial, there is minimal evidence regarding the safety and efficacy of methylprednisolone; we therefore assigned it a score of 1."

Answered by AI
~16 spots leftby Dec 2025