Inflammatory Bowel DiseasesPhase 1IBDIRNCT05587673
High Dose Steroid Therapy to Treat Flares in Patients With Inflammatory Bowel Disease (IBD)
A Phase 1 study testing Methylprednisolone in people with Inflammatory Bowel Diseases and Crohn Disease, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 25 years
- Conditions the study is for
- Inflammatory Bowel Diseases, Crohn Disease, Ulcerative Colitis
- What is being tested?
- Methylprednisolone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Oct 2022to 11 Oct 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Being tested
- Methylprednisolone
- Medical subject headings
- Inflammatory Bowel Diseases, Crohn Disease, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High dose steroid injected directly into the inflamed bowel segment(s) via its arterial blood supply.
| Study group | Role | What they receive |
|---|---|---|
| Methylprednisolone | Experimental | Participants who have failed first line therapy and are still experiencing flare symptoms. Receives: Drug: Methylprednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline through week 6
Secondary outcomes (2)
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.
Measured: Month 6
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.
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2022
- Study start6 Oct 2022
- Primary completion11 Oct 2023
- Study completion11 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Avnesh Thakor, Stanford University
- Investigators
- Avnesh Thakor, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05587673
- Sponsor's protocol ID
- 64154
- Acronym
- IBDIR
- Status last verified
- Nov 2024
- First submitted
- 14 Oct 2022
- Last updated
- 26 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05587673
- Acronym / sponsor ID
- IBDIR / 64154
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 6 Oct 2022 (actual)
- Primary completion
- 11 Oct 2023 (actual)
- Study completion
- 11 Oct 2024 (actual)
- First posted
- 20 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Methylprednisolone | Experimental | Drug: MethylprednisoloneParticipants who have failed first line therapy and are still experiencing flare symptoms. |
Who may qualify
- Ages
- 4 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MethylprednisoloneHigh dose steroid injected directly into the inflamed bowel segment(s) via its arterial blood supply. | Drug | Methylprednisolone |
Primary outcome
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.
2 secondary outcomes
Number of patients in which pre-procedural and procedural imaging can be correlated with clinical outcomes following therapy
Time frame: Month 6
Number of patients who have molecular changes correlated with improvement in symptoms following intraarterial steroid therapy.
Time frame: Month 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Avnesh Thakor, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Methylprednisolone in people with Inflammatory Bowel Diseases and Crohn Disease, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with symptomatic, imaging or biopsy related improvement in their IBD symptoms (time frame: Baseline through week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2024.